Hrugujc6q2qut9wgwtbw logo sgs

SGS Pharmaceutical Services

US

SGS has been a world leader in pharmaceutical outsourcing for decades, partnering with companies of all sizes, including the top 20 pharmaceutical companies in the world.

There is no better partner for high-quality analytical laboratory testing, clinical research and independent audit and certification services.

Our services use cutting-edge technology and highly qualified and experienced staff who stay abreast of the most recent developments in their field. Our aim is to provide a comprehensive package that is able to support clients ‘from molecule to market’, through research, clinical trials, product development, quality control testing, manufacture and supply. In addition, we provide robust pharma audit solutions for clients who are looking for advice on how to improve their processes, technology, or methodology. As a customer-driven company, our services are flexible enough to be used for a complete drug... Show more »

SGS has been a world leader in pharmaceutical outsourcing for decades, partnering with companies of all sizes, including the top 20 pharmaceutical companies in the world.

There is no better partner for high-quality analytical laboratory testing, clinical research and independent audit and certification services.

Our services use cutting-edge technology and highly qualified and experienced staff who stay abreast of the most recent developments in their field. Our aim is to provide a comprehensive package that is able to support clients ‘from molecule to market’, through research, clinical trials, product development, quality control testing, manufacture and supply. In addition, we provide robust pharma audit solutions for clients who are looking for advice on how to improve their processes, technology, or methodology. As a customer-driven company, our services are flexible enough to be used for a complete drug development outsourcing package or, as just stand-alone services.

Importantly, our services meet regulatory standards – both international and local – so you can be sure that yor product will progress towards market as quickly as possible, overcoming regulatory, quality, safety and efficacy hurdles.

Our experts are on hand to discuss how their services might be of use to let you stay ahead in your business. No matter whether we provide a complete package of pharmaceutical services or we provide support during periods of heavy activity, you can be sure to receive the same high levels of quality and integrity that we provide to all clients.

« Show less

SGS Pharmaceutical Services has not listed any services.

Spray Drying
Price on request
Request a quote for more information about this service.
Solvent Screening
Price on request

Organic solvents, many of them toxic, are used throughout the manufacturing processes of raw materials and finished products. These organic solvents must be reduced down to safe levels before these raw materials can be used to manufacture finished pharmaceutical products.
SGS can perform analytical testing for a wide variety... Show more »

Organic solvents, many of them toxic, are used throughout the manufacturing processes of raw materials and finished products. These organic solvents must be reduced down to safe levels before these raw materials can be used to manufacture finished pharmaceutical products.
SGS can perform analytical testing for a wide variety of organic solvents to ensure that Finished Products meet FDA and EP requirements for safe levels. Organic solvents are generally characterized by their level of toxicity. These classifications are:
Class 1: Solvents to be avoided; known or strongly suspected to be human carcinogens; environmental hazards
Class 2: Solvents to be limited; nongenotoxic animal carcinogens or possible causative agents of other irreversible toxicity; solvents suspected of other significant but reversible toxicities
Class 3: Solvents with low toxic potential; no health-based exposure limit is needed
SGS can also test for residual solvents that may not have sufficient toxicity data to be placed in one of these categories.
SGS will use methodology as described in USP <467> to test for residual solvents whenever possible. There are several solvents, though, that cannot be analyzed using the USP method. In these cases, SGS offers method development and full method validation services for solvents that cannot be tested for with standard methodology.
SGS also offers full method transfer services for validated client methods when they are available.

TECHNIQUES/TESTS
• Full certified cGMP documentation and laboratory practices
• Gas Chromatography with either flame-ionization detection or thermal-conductivity detection.
• Sample introduction by either headspace or direct-liquid samplers.
• Packed column or Capillary open-tubular column technology
• Instrument Control and Data Management using Waters Empower software

« Show less
USP <467>
Residual Solvents
Gas Chromatography
Flame ionization
Thermal conductivity
Gas Chromatograph with Headspace Autosampler
GC Agilent 6890
GC Agilent 7890
Autosampler Agilent 7697A
Autosampler Agilent G1888
Medical Device Testing
Price on request
Request a quote for more information about this service.
Drug Storage
Price on request

Storage capacity

Storage capacity

« Show less
Storage
25C/60RH
30C/65RH
40C/75RH
-70 to -80C
-20C
25C/75RH
2 to 8C
Forced Degradation Studies
Price on request

Forced Degradation and Stress Testing

Forced Degradation and Stress Testing

« Show less
Forced Degradation
Acid
Base
Dry Heat
Wet Heat
Oxidative
UV/Vis
Stress
Bioburden Testing
Price on request
Request a quote for more information about this service.
Bioburden
Microbial Examination Testing
Microbial Limits (USP <61> <62>)
Laminar Flow Hood
Stomecher
Class V
Manifolds
ICP-MS
Inductively Coupled Plasma Mass Spectrometry
Price on request
Request a quote for more information about this service.
ICP-MS
ICP-MS
Perkin Elmer NexION 300x
Product Release Testing
Price on request

cGMP Release Testing
Release testing is an important step to ensure the safety of your drugs. SGS provides you with breadth of services and the professional expertise to ensure that your raw materials, APIs, finished products and packaging materials are tested quickly and according to applicable cGMP regulations.
Our well... Show more »

cGMP Release Testing
Release testing is an important step to ensure the safety of your drugs. SGS provides you with breadth of services and the professional expertise to ensure that your raw materials, APIs, finished products and packaging materials are tested quickly and according to applicable cGMP regulations.
Our well equipped, state-of-the-art laboratories offer comprehensive testing services according to the pharmacopoeia (e.g. EP, USP, BP, JP) and to your specifications. Many of the top pharmaceutical companies entrust their quality control and testing to SGS.
Chemical and Physico-Chemical Testing of Pharmaceuticals
• Assays and chemical tests
• UV/Vis
• IR
• AAS
• Chromatographic tests
• HPLC
• GC
• IC
• ICP-MS
• Identification of active ingredients and impurities
• Physical and physico-chemical determinations
• pH
• Viscosity
• Melting point
• Particle size
• Osmolality and osmolarity
• Loss on drying
• Limit tests
• Heavy metals
• Ash
• Anions/Cations
• Residual solvents
• Volatile organic compounds (VOC)
• Pharmaceutical technical procedures
• Disintegration
• Dissolution
• Hardness
• Friability
• Sampling and analyses of water for pharmaceutical purposes and controlled process environments (e.g. TOC, conductivity)

SUB-SERVICES
Analytical Chemistry
Container Testing
Elemental Analysis
Karl Fisher Analysis
Impurity Analysis
Microbiology

« Show less
Impurity Identification
HPLC
analytical chemistry
TOC
ICP-MS
USP
EP
BP
JP
Dissolution
Residual Solvents
Conductivity
Heavy Metals
IC
Karl Fisher Analysis
UV/Vis
Viscosity
Container Testing
GC
IR
AAS
Elemental Analysis
Melting Point
Disintegration
Assays
Chromatographic tests
API Identification
pH
Particle Size
Air Jet Method
Sieve Method
Malvern
Osmolality
Osmolarity
Loss on Drying
Limit Tests
Ash
Anions/Cations
Volatile Organic Compounds
Hardness
Friability
Imipurity Analysis
Microbiology
Product Dissolution Testing
Price on request
Request a quote for more information about this service.
Dissolution
Dissolution Testing
Price on request
Request a quote for more information about this service.
Dissolution
Container Closure Integrity Testing
Price on request

Container closure integrity testing is designed to test the integrity of a container’s seal. The integrity of a container’s closure system is essential for maintaining sterility of a product over the course of its shelf life. SGS has over 25 years experience with various closure systems such as bottles, stoppered and sealed... Show more »

Container closure integrity testing is designed to test the integrity of a container’s seal. The integrity of a container’s closure system is essential for maintaining sterility of a product over the course of its shelf life. SGS has over 25 years experience with various closure systems such as bottles, stoppered and sealed vials, prefilled syringes and cartridges, etc.

TECHNIQUES INCLUDE
• Quantitative Dye Penetration by UV-Vis
o Involves exposing the product’s container to a dye solution under dynamic challenge conditions and utilizing UV-Vis analysis to determine if the container closure system remained intact during the challenge
o Options for pressure and/or vacuum
o Method development and validation available
• Qualitative Dye Penetration by Visual
o Involves exposing the product’s container to a dye solution under dynamic challenge conditions and utilizing a visual analysis to determine if the container closure system remained intact during the challenge
o Options for pressure and/or vacuum
• Microbial Challenge
o Involves immerging the product’s container (filled with sterile media) to a microbial solution and incubating to determine if the container closure system remained intact during the challenge
o Options for pressure, vacuum, and/or temperature cycling

« Show less
Dye by UV-Vis
Dye by Visual Inspection
Microbial Challenge
Impurity Analysis
Price on request
Request a quote for more information about this service.
Impurity Analysis
Extractable and Leachable Testing
Price on request

Extractables and leachables are relevant because it fundamentally has to do with compatibility of a contact system and a drug product formulation. Thus, it is critical to design a suitable extractables and leachables testing program that is specifically designed for our Client’s product.
Extractables are chemical species which... Show more »

Extractables and leachables are relevant because it fundamentally has to do with compatibility of a contact system and a drug product formulation. Thus, it is critical to design a suitable extractables and leachables testing program that is specifically designed for our Client’s product.
Extractables are chemical species which is forced out of a material under conditions at least as aggressive of normal product use conditions. Leachables are chemical species which migrates from a material under normal conditions into the drug product. Extractables and leachables may be composed of monomers and polymer additives such as antioxidants, plasticisers, stabilizers, dyes, metal catalysts and other harmful chemicals may potentially migrate into the product under storage conditions.
SGS provides a complete service for testing extractables in container materials and leachables in final products. These tests are conducted in cGMP compliant laboratories using technologies that detect ultra trace levels.
SGS’s services include:
• Plan an appropriate test strategy and data evaluation based on the available information
• Development of a tailored program for Extractables and Leachables
• Method development and validation of potential leachables
• Leachables studies on pharmaceutical products reporting and evaluation of results within the current guidelines
• Determination of the Analytical Estimation Threshold (AET) for Extractables
Calculation of the qualification threshold based on Safety Concern Threshold (SCT)

Please contact us and we can provide guidance for sampling and sending samples.

Methods:
LC-DAD/MS for non-volatile organic compounds (NVOC)
GC-FID/MS for semi-volatile organic compounds (SVOC)
HS-GC-FID/MS for volatile organic compounds (VOC)
ICP-OES or ICP-MS for inorganic elements

« Show less
Glass vials
Stoppers
Pre-filled syringes
Filters
Cartridges
Medical devices
Bottles
LC-DAD/MS for non-volatile organic compounds (NVOC)
GC-FID/MS for semi-volatile organic compounds (SVOC)
HS-GC-FID/MS for volatile organic compounds (VOC)
ICP-OES or ICP-MS for inorganic elements
Agilent 720 ICP-OES
Varian 820 ICP-MS
Waters Acquity UPLC PDA/QDA (MS)
Agilent G1530N with FID/MS/HS
Transdermal Patch
Facility Management
Price on request

Facility Validation

Facility Validation

« Show less
Clean Room Services
Price on request
Request a quote for more information about this service.
Clean Room Monitoring Services
Price on request
Request a quote for more information about this service.
Cleaning Validation Services
Price on request
Request a quote for more information about this service.
Disinfectant Efficacy Testing
Price on request
Request a quote for more information about this service.
Gas Testing
Price on request
Request a quote for more information about this service.
Environmental Monitoring
Price on request

Confirming that all aspects of your pharmaceutical production process are within a state of control is vital for meeting your regulatory obligations and ensuring that your products are fit for market. SGS’s environmental monitoring (EM) services for pharmaceutical and medical device production help confirm that critical areas such... Show more »

Confirming that all aspects of your pharmaceutical production process are within a state of control is vital for meeting your regulatory obligations and ensuring that your products are fit for market. SGS’s environmental monitoring (EM) services for pharmaceutical and medical device production help confirm that critical areas such as:
• Clean rooms
• Manufacturing Sites
• Sterile Packaging Sites
• Testing Sites
• Hoods - Laminar flow and biological safety hoods
are free from contamination of viable (living microorganisms) and non-viable particles. An EM program will help monitor the quality of controlled environments.
Our services include:
• Customized EM programs
o Clean room qualification
o Assessment of New and Existing Facilities Undergoing Changes
o Consulting, On Site Assessment, Sampling and Testing
o Qualification of Production Facilities after Installation, Construction, Standstill, etc.
o On Site Scientific Staffing – Temporary and FTE programs
• Air Sampling and Analysis
o Viable and Non-Viable Particulates
o Compressed Air and Gases
o Passive Air
• Surface Sampling and Analysis
o Equipment Surfaces
o Testing Surfaces
• Personnel Monitoring Sampling and Analysis
o Gowning Qualification
o Operator Monitoring
• Incubation and Enumeration
o Contact Plates (RODAC)
o Fallout Plates
o Air Strips
o Swabs
• Water Testing
o Purified Water System Validation and Routine Monitoring
o Compendial methods: USP, EP, JP
o Bacterial Endotoxin
o Total Organic Carbon (TOC)
o Conductivity
o Microbial bioburden
o Residuals e.g. metals
• EM Media Qualification
o Growth Promotion
o Neutralization Study
• Manufacturing Equipment
o Cleaning Validation and Routine Monitoring
o Verification of Cleaning process – Effectiveness and Impact on Product

« Show less
Water
Contact Plates
Air Sampler Strip
Fallout Plates
Swabs
Air Sampler Unit MAS 100
Environmental Contaminant Measurement
Price on request
Request a quote for more information about this service.
Water Quality Testing
Price on request

Water Testing
Water is a key component in the manufacturing of virtually all bio/pharmaceutical products. Water tests are used to monitor and ensure that the specified quality of water is used so not to compromise the quality of finished products.
There are many different grades of water (e.g. purified water, water for injection... Show more »

Water Testing
Water is a key component in the manufacturing of virtually all bio/pharmaceutical products. Water tests are used to monitor and ensure that the specified quality of water is used so not to compromise the quality of finished products.
There are many different grades of water (e.g. purified water, water for injection (WFI)) and depending on its use different specifications and quality attributes will apply.
Water tests typically consist of:
• Bioburden testing
• Endotoxin testing
• TOC and Conductivity
SGS can carry out water tests following various monographs (USP/EP/JP), as well as tailor water testing programs to meet the needs of clients.
Water purification systems must be validated to ensure that the specified quality of water is consistently produced.
If manufacturing plants are located near any of SGS’s Life Sciences Services laboratories, our technicians can perform the sampling on behalf of the client. Alternatively, samples can be collected by the client and shipped to an SGS laboratory for analysis. SGS can supply containers for collecting water samples.
All water purification systems must be monitored regularly to verify the quality of the water produced. Water purification systems can potentially harbor high levels of bacteria, and bacterial or chemical purity problems with water can compromise the quality of finished products.
Please contact your local laboratory from our network to discuss your purified water system validation requirements.

TECHNIQUES/TESTS
• Bacterial Endotoxin Testing (BET)/Limulus Amebocyte Lysate (LAL)
o Detection of endotoxin from Gram-negative bacteria present in water samples will ensure water of appropriate microbiological quality is being used.
• Heterotrophic Plate Count (HPC) and Coliforms
o High microbial bioburden in water systems may be an indication of inadequate maintenance and sanitization; therefore, it is important to detect this early on to prevent impact on the manufacturing process.
• Total Organic Carbon (TOC) and Conductivity
o An assessment of the chemical purity of water systems is critical in determining whether the system is in a state of quality control.
• Water System Validation
o All water purification systems must be monitored regularly to verify the quality of the water produced.

« Show less
endotoxin
TOC
Bioburden
USP
EP
JP
Bacterial Endotoxin Testing
LAL
Conductivity
Heterotrophic Plate Count
Coliforms
Water System Validation
Sterility testing
Price on request

Sterility testing must be performed on any product intended to be sterile such as large or small-volume parenterals, opthalmics, noninjectable preparations, antibiotics, oils, emulsions, medical devices, and more.
We test all products for sterility under aseptic conditions in a certified ISO 6 cleanroom within an ISO 5 laminar... Show more »

Sterility testing must be performed on any product intended to be sterile such as large or small-volume parenterals, opthalmics, noninjectable preparations, antibiotics, oils, emulsions, medical devices, and more.
We test all products for sterility under aseptic conditions in a certified ISO 6 cleanroom within an ISO 5 laminar airflow hood. The working conditions in which the tests are performed are monitored regularly by sampling of the working area of each test and by carrying out appropriate controls.
Membrane filtration is the testing method of choice for filterable products. We use a closed system of membrane filters having a nominal pore size not greater than 0.45µm whose effectiveness to retain microorganisms has been established, and all inhibiting compounds are rinsed using a suitable rinse solution.
Direct inoculation is the testing method of choice for items that cannot be filtered. In this method, the test sample is immersed directly into the required media.
For both test methods the samples are incubated for 14 days in the test media. Fluid thioglycollate medium is primarily intended for the culture of aerobic and anaerobic bacteria. Soy-bean casein digest medium is suitable for the culture of both fungi and aerobic bacteria.
We offer experience with generating protocols and performing method suitability tests (bacteriostasis/fungistasis) to validate the testing process, based on your product’s specific formulation, batch size, and fill volume. Our staff will determine the appropriate method for your product, whether it contains preservatives or bacteriostatic or fungistatic compounds. SGS ensures that pharmaceutical sterility testing is carried out in accordance with the European Pharmacopeia and USP <71> for pharmaceuticals and CFR 610.12 for biologics.

Techniques:
• Membrane filtration – for most water soluble products
• Direct inoculation – for items that cannot be filtered

« Show less
Membrane Filtration
USP <71>
Direct Inoculation
Microbiology Testing
Price on request

Microbiology
The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. FDA expects manufacturers to measure and characterize the bioburden of their products.
SGS’s microbiologists have a wealth of experience in applying USP and international methods to a wide variety of biologics... Show more »

Microbiology
The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. FDA expects manufacturers to measure and characterize the bioburden of their products.
SGS’s microbiologists have a wealth of experience in applying USP and international methods to a wide variety of biologics and traditional pharmaceuticals.
Recognized as the global benchmark for quality and integrity, SGS is committed to providing the best services in our class to all of our clients. Our team of microbiologists helps in determining the needs and expectations of our clients in order to satisfy regulatory requirements. At SGS, our scientific approach is supported by our technical knowledge and expertise in microbiological testing. With extensive method validation expertise, our team of microbiologists ensures the quality and integrity of all test results.

SUB-SERVICES
Antimicrobial Effectiveness Testing (AET)/Preservative Effectiveness Testing (PET)
Bacterial Endotoxin Testing (BET)/Limulus Amebocyte Lysate (LAL) Testing
Biological Indicator (BI) Testing
Bioburden Testing/Microbial Enumeration Test (MET)/Microbial Limits Test (MLT)
Method Verification
Water Testing

« Show less
LAL
Antimicrobial Effectiveness Testing (AET)
Preservative Effectiveness Testing (PET)
Bacterial Endotoxin Testing (BET)
Biological Indicator Testing (BI)
Bioburden Tesitng
Microbial Enumeration Test (MET)
Microbial Limits Test (MLT)
Water Testing
Method Verification
Karl Fischer Titration
Price on request
Request a quote for more information about this service.
Metrohm 831
Metrohm 888
Metrohm 890
Mettler Toledo C20
Elemental Analysis
Price on request

Carbon, Hydrogen, Nitrogen, Oxygen and Sulfur
Atomic Absorption Spectroscopy
Flame Photometry
ICP-OES Spectroscopy
ICP-MS Spectroscopy

Carbon, Hydrogen, Nitrogen, Oxygen and Sulfur
Atomic Absorption Spectroscopy
Flame Photometry
ICP-OES Spectroscopy
ICP-MS Spectroscopy

« Show less
USP <232>
USP <233>
Atomic Absorption Spectroscopy
Flame Photometry
ICP-OES Spectroscopy
ICP-MS Spectroscopy
Heavy Metals
Perkin Elmer NexION 300x
Perkin Elmer 2400
Perkin Elmer PinAAcle 900T
Cole Parmer 2655-00
Perkin Elmer Optima 8300
Package and Container Testing
Price on request
Request a quote for more information about this service.
USP <661.1>
USP <661.2>
USP <87>
Analytical Chemistry Services
Price on request

SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art cGMP analytical laboratories offer comprehensive testing services. Our analytical experts are ready to... Show more »

SGS provides the professional expertise and regulatory qualifications necessary to perform analytical testing of raw materials, APIs, finished products, packaging material and medical devices. Well-equipped state-of-the-art cGMP analytical laboratories offer comprehensive testing services. Our analytical experts are ready to assist with the following analytical services:
CHEMICAL AND PHYSICO-CHEMICAL TESTING
■R&D projects, Method Development, Method Qualification, Method Validation, Method Transfer, Method Verification, remedial/retrospective method validation, Forced Degradation studies for stability indicating methods, Product and Process related impurities.
■Quality control release testing, Active pharmaceutical ingredient and excipients testing, drup product release and stability testing, Stability storage and testing, Extractables and leachables analysis, Dissolution USP <711> Method development and routine analysis, Metals analysis (AA, GFAA, and ICP), Elemental Impurities, Residual Solvents USP <467>, Compendial monograph testing per the USP, EP, BP, JP, FCC and ACS
■Chromatographic tests (e.g. HPLC, UPLC-MS, GC-HS/MS, CE, GC-FID, IC, ICP-OES/MS, TLC), Wet chemistry analysis, Karl Fisher analysis, Spectrophotometric Analysis (FTIR, and UV/Vis), Viscosity analysis (Brookfield), Container testing, Container integrity testing-Dye Ingress, Package integrity, Glass, Plastic and Rubber testing as per USP/EP/JP, Light transmission and cleaning studies, USP <661>Physiochemical tests for nonvolatile residue, residue on ignition, heavy metals and buffering capacity.
■Micro USP <61>,<62>, Antibiotic Assay, Dissinfection qualification and disinfectant efficacy determinations, Environmental monitoring, Light Obscuration,-HIAC testing, Membrane filtration sterility testing, Preservative challenge, Cytotoxicity testing, Bacterial Endotoxin, water sampling and analysis for pharmaceutical purpose and controlled process environments, water activity testing, bacterial and fungal resistance testing, Growth promotion, AMES, Organism Identification

« Show less
HPLC
Cytotoxicity
Stability Testing
Ames
Bacterial Endotoxin
Membrane Filtration
FTIR
ICP
USP <467>
ICP-MS
USP
EP
BP
JP
Dissolution
FCC
ACS
Residual Solvents
Method Verification
Heavy Metals
R&D
Method Development
Method Qualification
Method Validation
Method Transfer
Remedial/Retrospective Method Validation
Forced Degredation
Stability Indicating Methods
Quality Control Release Testing
API
Excipient Testing
Drug Product Release
Stability Storage
Extractables and Leachables
USP <711>
Metals Analysis
AA
GFAA
Elemental Impurities
Compendial Monograph testing
Chromotography Testing
UPLC-MS
GC-HS/MS
CE
GC-FID
IC
ICP-OES
TLC
Wet Chemistry Analysis
Karl Fisher Analysis
Spectophotometric Analysis
UV/Vis
Viscosity
Container Testing
Container Integrity Testing
Dye Ingress
Package Integrity
Glass
Plastic
Rubber Testing
Light Transmission
Cleaning Studies
USP <661>
Physiochemical Tests
Nonvolatile Residue
Residue on Ignition
Buffering Capacity
USP <61><62>
Antibiotic Assay
Dissinfection Qualification
Disinfectant Efficacy Determination
Environmental Monitoring
Light Obscuration
-HIAC Testing
Preservative Challenge
Water Sampling and Analysis
Growth Promotion
Organism Identification
Consumer Product Testing Services
Price on request

Chemical and Physicochemical Testing of Pharmaceuticals

Chemical and Physicochemical Testing of Pharmaceuticals

« Show less
Raw Material Testing
Price on request

Raw material testing is a vital step to ensure that your supplier is meeting your specifications and gives you insight into the nature of your raw materials. SGS provides testing that will verify the
• Identity
• Safety
• Suitability for your product
Ultimately, our aim is to give you confidence that you are producing a... Show more »

Raw material testing is a vital step to ensure that your supplier is meeting your specifications and gives you insight into the nature of your raw materials. SGS provides testing that will verify the
• Identity
• Safety
• Suitability for your product
Ultimately, our aim is to give you confidence that you are producing a safe, high quality product that meets the expectations of customers and regulatory bodies.
Our network of laboratories offers comprehensive testing services according to the most recent pharmacopeia (USP/NF, JP, EP, BP, FCC, and ACS) under cGMP conditions. From method transfers of vendor methods, to developing and validating a custom method for your product, when you work with SGS, you have a partner with a strong history of delivering to a consistently high standard.

• SGS performs most USP/NF, JP, EP, BP, FCC, and ACS compendia methods complete with method verifications. SGS can also test custom materials using general chapters after compendia verifications.

• Our SGS labs will transfer in-house methods from your lab or CMO for your release testing needs. SGS has many years experience working with hundreds of vendors and suppliers.

• Our SGS labs are also well equipped with the latest instrumentation to perform customized method development and validations for your raw materials and excipients.

• SGS can ensure purity of raw materials by performing assays by HPLC, UPLC, GC and titrations.

• Identity confirmation by IR, UV, and colorimetric techniques are common in all SGS labs.

• SGS also provides a variety of contamination testing such as residual solvent testing by GC and IC, and heavy metals testing by ICP-OES, ICP-MS, and AAS.

Sub-Services:
• Analytical Chemistry – SGS can provide method transfers, method development and validation, as well as compendia verification of existing methods for new products and uses.

• Container Testing – SGS can test all your containers for physiochemical properties as well as moisture permeation and extractables and leachables testing. We have extensive experience with glass and plastic bottles, materials for blister packs and pouches, and much more.

• Elemental Analysis – SGS can perform CHN analysis on all materials, as well as ICP for heavy metals and IC for ion analysis.

• Karl Fisher Analysis – SGS can perform both volumetric titration method and the coulometric titration method. Our labs can also test for water content by LOD as well.
.
• Microbiology – SGS is versed in multiple microbiological techniques that can ensure the purity and safety of raw materials reducing the risk of contamination issues with final products.

• Residual Solvent Analysis - SGS can perform analytical testing for a wide variety of organic solvents to ensure that raw materials meet FDA and EP requirements for safe levels.

• Spectrophotometric Analysis – SGS offers many methods to analyze raw materials including IR, UV/Vis, AAS, and ICP.

• Sterility Testing – Sterility testing is vital for any products which will be marketed as “Sterile”. SGS is proficient in both membrane filtration and direct injection techniques.

• Thermodynamic Property Analysis – SGS analyzes raw materials for a variety of properties using techniques such as DSC, TGA and melting point.

• Water Testing – SGS offers a wide variety of water testing ranging from Ultra-purified-DI water to potable drinking water, all used as raw materials.

« Show less
HPLC
UPLC
analytical chemistry
USP <467>
ICP-MS
EP
BP
JP
USP/NF
FCC
ACS
Water Testing
Method Verification
Heavy Metals
Method Development
Method Validation
Method Transfer
Extractables and Leachables
IC
ICP-OES
Karl Fisher Analysis
Container Testing
Compendial Method Testing
GC
Titration
IR
UV
Colorimetric
Contamination Testing
Residual Solvent Testing
AAS
Moisture Permeation
Elemental Analysis
Ion Analysis
Volumetric Titration
Coulometric Titration
Water Content by LOD
Microbiological Testing
Sterility Testing
Thermodynamic Property Analysis
DSC
TGA
Melting Point
Microbial Limit Testing
Price on request

Bioburden/Microbial Enumeration Test (MET)/Microbial Limits Test (MLT)

Bioburden/Microbial Enumeration Testing (MET) is carried out on pharmaceutical articles of all kinds from raw materials to finished forms, as well as medical devices or packages, which are categorized as non-sterile to determine the microbial load on these... Show more »

Bioburden/Microbial Enumeration Test (MET)/Microbial Limits Test (MLT)

Bioburden/Microbial Enumeration Testing (MET) is carried out on pharmaceutical articles of all kinds from raw materials to finished forms, as well as medical devices or packages, which are categorized as non-sterile to determine the microbial load on these products.

Typically, bioburden testing is required as part of a sterilization program to ensure products are properly sterilized throughout the program and is also a test routinely conducted during the release of a product (e.g. pharmaceuticals, biopharmaceuticals, medical devices) to market to demonstrate that the manufacturing process remains in control.

Regulatory bodies such as the FDA expect pharmaceutical and medical device companies to monitor the bioburden load in products used for humans and animals to ensure product safety; SGS performs bioburden testing (MET) according to procedures outlined in the following USP guidances:
- USP <61> is an enumeration test for quantification of microorganisms in non-sterile products or raw materials to determine the total aerobic microbial count (TAMC) and total yeast and mold count (TYMC).
- USP <62> tests for the presence or absence of specific organisms in the product, which may include any or all of the following depending on the product’s use: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Salmonella species, Clostridia species and bile tolerant Gram negative bacteria.

USP <61> and USP <62> tests provide harmonization to the European Pharmacopeia methods for testing non-sterile pharmaceuticals. USP requires that prior to routine enumeration testing a method suitability test must be performed. Amount of sample required for the test is 10 grams/mL/patches and for the suitability test is 30 to 40 grams/mL/patches.

MET may include assessment of the physical characteristics and inherent antimicrobial properties of the product in question. At SGS we will gladly provide guidance to our clients to ensure appropriate testing is conducted on products specific to our clients.

During testing of bioburden, SGS utilizes the following techniques:

  • Membrane Filtration Method
    o This is an effective quantitative technique used to isolate colonies of bacteria and fungi from a fluid sample using a membrane filter and vacuum. Because a larger quantity of sample can be evaluated and bactericidal agents removed using this technique, it is the preferred choice for bioburden evaluation.

  • Standard Plate Count

o Pour Plate Method
 This quantitative method is used to isolate colonies of bacteria and fungi by plating a sample preparation directly into an empty P-etri dish and adding nutrient agar to allow the growth of any microorganisms that may be present. This is typically used for samples with higher concentration of bacteria present or if the physical characteristics of the sample will not allow it to be tested using the membrane filtration method.

o Spread Plate Method
 This quantitative method is used to isolate colonies of bacteria and fungi by plating a sample preparation directly onto a nutrient agar plate. This is typically used for samples with higher concentration of bacteria present or if the physical characteristics of the sample will not allow it to be tested using the membrane filtration method.

  • Most Probable Number
    o This serial dilution test is used to measure the concentration of bacteria in a sample. This method is useful for samples with particulate matter that may interfere with accurate colony counts and for samples that may have a low concentration of bacteria.
« Show less
Microbial Limits (USP <61>)
Bioburden
Membrane Filtration
Microbial Limits (USP <61> <62>)
Standard Plate Count
Spread Plate Method
Pour Plate Method
Antimicrobial Effectiveness Testing
Price on request

Antimicrobial Effectiveness Testing (AET)

Antimicrobial Effectiveness Testing (AET) or Preservative Effectiveness Testing (PET) is performed to evaluate if a product is able to withstand microbial contamination during use. This test is used for all injections packaged in multiple-dose containers and products that contain... Show more »

Antimicrobial Effectiveness Testing (AET)

Antimicrobial Effectiveness Testing (AET) or Preservative Effectiveness Testing (PET) is performed to evaluate if a product is able to withstand microbial contamination during use. This test is used for all injections packaged in multiple-dose containers and products that contain antimicrobial preservatives. Different forms of the product include aqueous-based, multiple-dose topical and oral dosage forms, and various pharmaceutical dosage forms such as ophthalmic, otic, nasal, irrigation and dialysis fluids.

Testing is performed per USP <51> Antimicrobial Effectiveness Testing, EP 5.1.3 Efficacy of Antimicrobial Preservation and CTFA Preservative Challenge Testing. Various challenge microorganisms are introduced into non-sterile products during the testing process to determine the level of antimicrobial effectiveness due to the addition of preservatives. Microorganisms are chosen based on likely contaminants to a drug product during or subsequent to the manufacturing process; however, supplemental microorganisms may be added in addition to the test microorganisms described in the compendial method.

If testing sterile articles packaged in multiple-dose containers, preservatives are added to the product to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses. Again, challenge microorganisms will be chosen based on likely contaminants during use. Packaging components, especially dispensing closures, can be important considerations in preventing microbial contamination during consumer use.

The following microorganisms are required per USP <51>: Candida albicans, Aspergillus brasiliensis, Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus.

The test consists of two parts:

• Suitability of the Counting Method
o This test is important to neutralize any residual preservatives that may be present in the recovery agar to obtain accurate plate counts of survivor microorganisms. This is determined by adding challenge microorganisms to product dilutions and saline controls to examine whether the diluted product exhibits any antimicrobial properties. If there is biocidal activity, chemical neutralizers may be incorporated into the testing scheme or further product dilution.

• Testing of Products
o Challenge microorganisms are added to the product and microorganisms that survived the preservative system are enumerated at different time intervals lasting over 28 days.

During testing of bioburden, SGS utilizes the following techniques:

  • Membrane Filtration Method
    o This is an effective quantitative technique used to isolate colonies of bacteria and fungi from a fluid sample using a membrane filter and vacuum. Because a larger quantity of sample can be evaluated and bactericidal agents are removed using this technique, it is the preferred choice for bioburden evaluation.

  • Standard Plate Count

o Pour Plate Method
 This quantitative method is used to isolate colonies of bacteria and fungi by plating a sample preparation directly into an empty Petri dish and adding nutrient agar to allow the growth of any microorganisms that may be present. This is typically used for samples with higher concentration of bacteria present or if the physical characteristics of the sample will not allow it to be tested using the membrane filtration method.

o Spread Plate Method
 This quantitative method is used to isolate colonies of bacteria and fungi by plating a sample preparation directly onto a nutrient agar plate. This is typically used for samples with higher concentration of bacteria present or if the physical characteristics of the sample will not allow it to be tested using the membrane filtration method.

This test is important because the antimicrobial activity of the preparation in its final container is evaluated over the period of validity to ensure that such activity has not been impaired by storage conditions. While the antimicrobial effectiveness test is not a batch release test, it is expected that these products comply with the specifications set forth in the compendial method. Because of this, it is critical to have some level of post-market stability program in place.

SGS facilities contain GMP-compliant stability chambers dedicated to storing client products. These chambers are continuously monitored for both temperature and humidity to ensure that our client product is maintained in its proper storage conditions.

TECHNIQUES/TESTS
Antimicrobial Effectiveness Testing – Method Suitability
• This test is important to neutralize any residual preservatives that may be present in the recovery agar to obtain accurate plate counts of survivor microorganisms. This is determined by adding challenge microorganisms to product dilutions and saline controls to examine whether the diluted product exhibits any antimicrobial properties. If there is biocidal activity, chemical neutralizers may be incorporated into the testing scheme or further product dilution.
Antimicrobial Effectiveness Testing – Routine Test
• Membrane Filtration, Pour Plate or Spread Plate Method

« Show less
Membrane Filtration
USP
EP
CTFA
Preservative Efficacy
Antimicrobial Preservative Effectiveness
Standard Plate Count
Spread Plate Method
Pour Plate Method
Method Validation
Price on request

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.
We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test... Show more »

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.
We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes. This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures, Methodology by the ICH (Q2A, Q2B) and FDA guidelines.
Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (lab-to-lab), complete or partial revalidation and comprehensive documentation (transfer plan, protocol, report).
Whether SGS’s Life Science Services is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

Method Feasibility (Pilot Studies)
Method feasibility will be performed as an initial evaluation of the fit for purpose status of the analytical methodology or as an initial evaluation of the fit for purpose status of SGS in-house analytical methodology applied to the client’s product. Method feasibility also includes minor non-method altering optimization to ensure compatibility with SGS-LSS technology and compliance systems. When acceptance criteria have been defined by the Client, the Pilot Studies will incorporate some assessment of these acceptance criteria. On the completion of feasibility assessment, a GO/No-GO decision will be communicated prior to proceeding to method pre-validation, qualification or validation.

Below are some examples of SGS’s method feasibility services but are not limited to:
- Development of a method feasibility / pilot study plan
- Execution of study
- Consultation with our experienced scientific team to develop a strategy prior to and after completion of a method feasibility study

Method Optimization
Based on the outcome of the feasibility phase (pilot studies) of the project, methods requiring additional optimization may be optimized to assure that the fit-for-purpose status of the method is met. In the circumstance where optimization is required, the optimization strategy is discussed and agreed upon by the Client and SGS prior to initiation of the work.

Below are some examples of SGS’s method optimization services but are not limited to:
- Development of a method optimization plan
- Execution of method optimization study to meet fit-for-purpose status of the analytical method
- Finalization of suitable test method

Method Verification
Method Verification is applicable only to compendial methods. Verification of a compendia procedure is the demonstration that a laboratory is capable of replicating with an acceptable level of performance a standard method. Verification under conditions of use is demonstrated by meeting system suitability specifications established for the method, as well as a demonstration of accuracy and precision or other method parameters for the type of method. Method performance is accomplished by using performance characteristics such as:
• blanks in chemistry, or un-inoculated media in microbiology, to assess contamination;
• laboratory control samples - spiked samples for chemistry or positive culture controls for microbiology, to assess accuracy;
• precision based on the analysis of duplicates;
• calibration check standards analyzed periodically in the analytical batch for quantitative analyses; and
• monitoring quality control samples, usually through the use of control charts.
(above description obtained from http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm)

Below are some examples of SGS’s method verification services but are not limited to:
- Development of a method verification protocol
- Execution of method verification
- Provision of final method verification report for SGS QA department and Client approval
- Preparation of testing guidelines specific for the client’s product

Method pre-Validation/Qualification
Method pre-Validation/Qualification will be performed on non-compendial methods when acceptance criteria have to be defined. Typically, method pre-validation / qualifications are conducted at the early stages of drug development e.g. during comparability studies, product characterization and SGS can provide advice wherever necessary.
During pre-Validation/Qualification, a selection of Method Validation parameters outlined in ICH Q2(R1) and/or applicable regulatory guidelines / standards will be assessed in order to define appropriate acceptance criteria to be used during the Method Validation. The set of parameters to be assessed may be discussed and agreed upon by the Client and SGS to meet the intended application of the method(s). A method cannot fail a method pre-validation / qualification and instead, the method is optimized until meeting the appropriate acceptance criteria or rejected.

Below are some examples of SGS’s method pre-validation / qualification services but are not limited to:
- Provision of consultative advice on method pre-validation / qualification
- Development of a method pre-validation / qualification plan
- Execution of method pre-validation / qualification plan
- Provision of draft / final reports for approval

Method Validation

A Method Validation process is used to confirm that an analytical method for a specific test is suitable for its intended use and is a crucial process for adherence to current Good Manufacturing Guidelines (cGMP) and Good Laboratory Practice (GLP). Typically, non-standard and laboratory-developed methods need method validation.

At SGS, Method Validation is performed as per requirements outlined in ICH Q2(R1) and/or applicable regulatory guidelines. The activity is planned and assigned to qualified personnel. The method’s performance characteristics are based on the intended use of the method. For example, if the method will be used for qualitative analysis, there is no need to test and validate the method’s linearity over the full dynamic range of the equipment. Method Validation will be performed as per requirements outlined in ICH Q2(R1) and/or applicable regulatory guidelines / standards. The following are some typical validation characteristics which should be considered:
o accuracy,
o precision,
o specificity,
o detection limit,
o limit of quantitation,
o linearity,
o range, and
o ruggedness and robustness.
(above description obtained from http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm)

Below are some examples of SGS’s method validation services but are not limited to:
- Provision of consultative advice on method validation
- Development of a method validation plan
- Execution of method validation plan
- Provision of draft / final method validation reports to be approved by both SGS QA department and the client
- Provision of study protocols for routine testing following method validation

Method Transfer
Method transfers are applicable only to validated methods ensuring consistent results and validated status between various laboratories and different sites.

A typical method transfer service at SGS may include but not limited to the following:
- Method transfer plan / protocol preparation, which should include outline of transfer tests and acceptance criteria, which will be approved by the Client and SGS
- Execution of method transfer protocol in regulatory compliant laboratories / sites
- Issuance of a transfer report and necessary transfer documentation
- SGS’s QA department and the Client must approve the final report

« Show less
Method development
Price on request

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.
We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test... Show more »

The expert personnel at SGS laboratories have extensive knowledge and experience in pharmaceutical method development and validation for raw materials, APIs, finished products, cleaning, and bioanalytical testing.
We offer development and documentation of analytical protocols and reports for proprietary and non-proprietary test methods and manufacturing processes. This is conducted in compliance with the Notes for Guidance Validation of Analytical Procedures, Definitions and Terminology and Validation of Analytical Procedures, Methodology by the ICH (Q2A, Q2B) and FDA guidelines.
Once a method is validated, it may require transfer. Method transfer may involve comparative testing, co-validation between two sites (lab-to-lab), complete or partial revalidation and comprehensive documentation (transfer plan, protocol, report).
Whether SGS’s Life Science Services is the developing or the receiving laboratory, we can assist you with your method transfer requirements.

Method Feasibility (Pilot Studies)
Method feasibility will be performed as an initial evaluation of the fit for purpose status of the analytical methodology or as an initial evaluation of the fit for purpose status of SGS in-house analytical methodology applied to the client’s product. Method feasibility also includes minor non-method altering optimization to ensure compatibility with SGS-LSS technology and compliance systems. When acceptance criteria have been defined by the Client, the Pilot Studies will incorporate some assessment of these acceptance criteria. On the completion of feasibility assessment, a GO/No-GO decision will be communicated prior to proceeding to method pre-validation, qualification or validation.

Below are some examples of SGS’s method feasibility services but are not limited to:
- Development of a method feasibility / pilot study plan
- Execution of study
- Consultation with our experienced scientific team to develop a strategy prior to and after completion of a method feasibility study

Method Optimization
Based on the outcome of the feasibility phase (pilot studies) of the project, methods requiring additional optimization may be optimized to assure that the fit-for-purpose status of the method is met. In the circumstance where optimization is required, the optimization strategy is discussed and agreed upon by the Client and SGS prior to initiation of the work.

Below are some examples of SGS’s method optimization services but are not limited to:
- Development of a method optimization plan
- Execution of method optimization study to meet fit-for-purpose status of the analytical method
- Finalization of suitable test method

Method Verification
Method Verification is applicable only to compendial methods. Verification of a compendia procedure is the demonstration that a laboratory is capable of replicating with an acceptable level of performance a standard method. Verification under conditions of use is demonstrated by meeting system suitability specifications established for the method, as well as a demonstration of accuracy and precision or other method parameters for the type of method. Method performance is accomplished by using performance characteristics such as:
• blanks in chemistry, or un-inoculated media in microbiology, to assess contamination;
• laboratory control samples - spiked samples for chemistry or positive culture controls for microbiology, to assess accuracy;
• precision based on the analysis of duplicates;
• calibration check standards analyzed periodically in the analytical batch for quantitative analyses; and
• monitoring quality control samples, usually through the use of control charts.
(above description obtained from http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm)

Below are some examples of SGS’s method verification services but are not limited to:
- Development of a method verification protocol
- Execution of method verification
- Provision of final method verification report for SGS QA department and Client approval
- Preparation of testing guidelines specific for the client’s product

Method pre-Validation/Qualification
Method pre-Validation/Qualification will be performed on non-compendial methods when acceptance criteria have to be defined. Typically, method pre-validation / qualifications are conducted at the early stages of drug development e.g. during comparability studies, product characterization and SGS can provide advice wherever necessary.
During pre-Validation/Qualification, a selection of Method Validation parameters outlined in ICH Q2(R1) and/or applicable regulatory guidelines / standards will be assessed in order to define appropriate acceptance criteria to be used during the Method Validation. The set of parameters to be assessed may be discussed and agreed upon by the Client and SGS to meet the intended application of the method(s). A method cannot fail a method pre-validation / qualification and instead, the method is optimized until meeting the appropriate acceptance criteria or rejected.

Below are some examples of SGS’s method pre-validation / qualification services but are not limited to:
- Provision of consultative advice on method pre-validation / qualification
- Development of a method pre-validation / qualification plan
- Execution of method pre-validation / qualification plan
- Provision of draft / final reports for approval

Method Validation

A Method Validation process is used to confirm that an analytical method for a specific test is suitable for its intended use and is a crucial process for adherence to current Good Manufacturing Guidelines (cGMP) and Good Laboratory Practice (GLP). Typically, non-standard and laboratory-developed methods need method validation.

At SGS, Method Validation is performed as per requirements outlined in ICH Q2(R1) and/or applicable regulatory guidelines. The activity is planned and assigned to qualified personnel. The method’s performance characteristics are based on the intended use of the method. For example, if the method will be used for qualitative analysis, there is no need to test and validate the method’s linearity over the full dynamic range of the equipment. Method Validation will be performed as per requirements outlined in ICH Q2(R1) and/or applicable regulatory guidelines / standards. The following are some typical validation characteristics which should be considered:
o accuracy,
o precision,
o specificity,
o detection limit,
o limit of quantitation,
o linearity,
o range, and
o ruggedness and robustness.
(above description obtained from http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm)

Below are some examples of SGS’s method validation services but are not limited to:
- Provision of consultative advice on method validation
- Development of a method validation plan
- Execution of method validation plan
- Provision of draft / final method validation reports to be approved by both SGS QA department and the client
- Provision of study protocols for routine testing following method validation

Method Transfer
Method transfers are applicable only to validated methods ensuring consistent results and validated status between various laboratories and different sites.

A typical method transfer service at SGS may include but not limited to the following:
- Method transfer plan / protocol preparation, which should include outline of transfer tests and acceptance criteria, which will be approved by the Client and SGS
- Execution of method transfer protocol in regulatory compliant laboratories / sites
- Issuance of a transfer report and necessary transfer documentation
- SGS’s QA department and the Client must approve the final report

« Show less
Technology Transfer Services
Price on request

Support to cGMP manufacturing

Support to cGMP manufacturing

« Show less
Pharmaceutical Product Development Consulting
Price on request

for ANDA (Generic) following QbD approach

for ANDA (Generic) following QbD approach

« Show less
Chemical Stability Testing
Price on request

From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.

With more than 20 years experience and more than 100,000 samples on storage globally, SGS’s Life Science Services group has the skills and capacity to handle your... Show more »

From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.

With more than 20 years experience and more than 100,000 samples on storage globally, SGS’s Life Science Services group has the skills and capacity to handle your stability projects.

We provide our customers with a complete range of storage conditions in numerous climatic walk-in chambers, climatic cabinets, refrigerators and freezers with a total storage capacity more than 22,000 cubic feet.

Services include:
• Support in designing studies for real time, stress tests and photostability studies
• Development and validation of stability indicating methods
• Examination of stability-relevant parameters
• Storage and management of stability samples
• Interim reports for every testing period
• Comprehensive final report

Climatic Zones include:
25C/60% r.h.
30C/60% r.h.
30C/65% r.h.
40C/75% r.h.
40C/ NMT 25% r.h.
5C
-20C
-80C
Custom conditions

« Show less
Pharmaceutical Product Testing
Price on request

Finished Product Testing
Analytical Chemistry
Antimicrobial Effectiveness Testing (AET)
Bacterial Endotoxin Testing (BET) / LAL Testing
Sterility Testing
Disintegration
Dissolution
Microbial Limits Test
Stability Studies

Finished Product Testing
Analytical Chemistry
Antimicrobial Effectiveness Testing (AET)
Bacterial Endotoxin Testing (BET) / LAL Testing
Sterility Testing
Disintegration
Dissolution
Microbial Limits Test
Stability Studies

« Show less
analytical chemistry
Dissolution
LAL
Antimicrobial Effectiveness Testing (AET)
Bacterial Endotoxin Testing (BET)
Microbial Limits Test (MLT)
Sterility Testing
Disintegration
Stability Studies
Product Stability Testing
Price on request

From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.

With more than 20 years experience and more than 100,000 samples on storage globally, SGS’s Life Science Services group has the skills and capacity to handle your... Show more »

From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.

With more than 20 years experience and more than 100,000 samples on storage globally, SGS’s Life Science Services group has the skills and capacity to handle your stability projects.

We provide our customers with a complete range of storage conditions in numerous climatic walk-in chambers, climatic cabinets, refrigerators and freezers with a total storage capacity more than 22,000 cubic feet.

Services include:
• Support in designing studies for real time, stress tests and photostability studies
• Development and validation of stability indicating methods
• Examination of stability-relevant parameters
• Storage and management of stability samples
• Interim reports for every testing period
• Comprehensive final report

Climatic Zones include:
25C/60% r.h.
30C/60% r.h.
30C/65% r.h.
40C/75% r.h.
40C/ NMT 25% r.h.
5C
-20C
-80C
Custom conditions

« Show less
Excipients
Price on request

Excipient Screening

Excipient Screening

« Show less
Physical Analysis Methods
Price on request
Request a quote for more information about this service.
Particle Analysis and Characterization
Price on request
Request a quote for more information about this service.
Hach HIAC
Olympus BX53 Microscope
Thermogravimetric Analysis (TGA)
Thermogravimetric Analysis
Price on request
Request a quote for more information about this service.
Differential Scanning Calorimetry (DSC)
Price on request
Request a quote for more information about this service.
TA Instruments Discovery
X-Ray Powder Diffraction
Price on request
Request a quote for more information about this service.
Bruker D2 Phaser
Drug Formulation Evaluation
Price on request

Method Qualification and Validation to Support Formulations

Method Qualification and Validation to Support Formulations

« Show less
Beckman pHI 360
Orion 2 Star
Mettler Toledo 7 Compact
VWR Symphony B10P
Chemical Analysis
Price on request

Chemical and Physicochemical Testing of Pharmaceuticals

Chemical and Physicochemical Testing of Pharmaceuticals

« Show less
Thermodynamic Property Analysis
Price on request
Request a quote for more information about this service.
Endotoxin Testing
Price on request

Bacterial Endotoxin Testing (BET)/Limulus Amebocyte Lysate (LAL) Test

Throughout the development process and prior to final release to the market, bacterial endotoxin testing (BET) is essential. SGS tests for endotoxin in several areas of drug manufacturing and production including raw material testing, bulk lot release testing... Show more »

Bacterial Endotoxin Testing (BET)/Limulus Amebocyte Lysate (LAL) Test

Throughout the development process and prior to final release to the market, bacterial endotoxin testing (BET) is essential. SGS tests for endotoxin in several areas of drug manufacturing and production including raw material testing, bulk lot release testing and final product release testing for a variety of pharmaceuticals, biologics and medical devices.
Bacterial endotoxin is a fever producing byproduct of Gram-negative bacteria commonly known as pyrogen; detection of endotoxin in samples may be an indicator of the presence of bacterial contaminants within a manufacturing process. It is important to detect any possible contamination during the early stages in time to remediate the situation and take any necessary actions to avoid proliferation. This method replaces the rabbit pyrogen test.
We provide sensitive qualitative and quantitative methods to meet all pharmacopoeial requirements, such as gel clot, kinetic chromogenic and kinetic turbidimetric. With our experienced staff, SGS will be there with you in all phases of drug development to help ensure that your products are pyrogen-free. BET/LAL) testing is conducted in accordance to USP <85>.

Please contact us for guidance regarding sampling and sending samples.

Methods
o Kinetic Turbidimetric
 This technique quantifies the level of bacterial endotoxin present in samples by measuring the increase in turbidity in the presence of a reactant, lysate. A microplate reader is utilized to run the assay.
o Kinetic Chromogenic
 This technique quantifies the level of bacterial endotoxin present in samples by measuring color change. When endotoxin present in sample reacts with lysate, chromophore is cleaved and causes a yellow color that is measured spectrophotometrically. A microplate reader is utilized to run the assay.
o Gel clot method Gel Clot Method
 This method measures the presence or absence of endotoxins in samples by the development of an opaque gel in the presence of sufficient levels of endotoxin. In cases where a result cannot be obtained using a photometric method, the gel clot method will be used.

« Show less
LAL assay
Kinetic Chromogenic
Chromogenic
Gel Clot
Kinetic Turbidimetric
Turbidimetric
Bacterial Endotoxin
USP <85>
ELx808 Microplate Reader
Lonza KQCL software and reagents
37+-1 degree C Waterbath
Micropipettor
Depyrogenation Oven
Vortex mixer
pH Meter
Analytical Balance
Reagents from Associates of Cape Cod
Project Management & Consulting Services
Price on request
Request a quote for more information about this service.
Experimental Design
Price on request
Request a quote for more information about this service.
Clinical Research
Price on request
Request a quote for more information about this service.
Clinical Drug Management
Price on request
Request a quote for more information about this service.
Biology
Price on request
Request a quote for more information about this service.
Cells and Tissues
Price on request
Request a quote for more information about this service.
Testing of Cell Lines
Price on request
Request a quote for more information about this service.
Microbiology, Virology, and Parasitology
Price on request
Request a quote for more information about this service.
Antimicrobial Activity Testing
Price on request
Request a quote for more information about this service.
Imaging & Spectroscopy
Price on request
Request a quote for more information about this service.
Spectroscopy
Price on request
Request a quote for more information about this service.
Mass Spectrometry
Price on request
Request a quote for more information about this service.
Other Mass Spectrometry Methods
Price on request
Request a quote for more information about this service.
Chemistry and Materials
Price on request
Request a quote for more information about this service.
Material Characterization Services
Price on request
Request a quote for more information about this service.
Chemical Engineering and Processing
Price on request
Request a quote for more information about this service.
Formulation & Manufacturing
Price on request
Request a quote for more information about this service.
Product Development & Testing
Price on request
Request a quote for more information about this service.
Product Quality Control and Assurance
Price on request
Request a quote for more information about this service.
Lab and Facility Services
Price on request
Request a quote for more information about this service.
Cleaning & Sterilization Services
Price on request
Request a quote for more information about this service.
Packaging
Price on request
Request a quote for more information about this service.
Engineering & Devices
Price on request
Request a quote for more information about this service.
Calorimetry
Price on request
Request a quote for more information about this service.
Strength Analysis
Price on request
Request a quote for more information about this service.
Thermal Analysis Services
Price on request
Request a quote for more information about this service.
Marketing, Business Development & Commercialization Services
Price on request
Request a quote for more information about this service.
Drug Discovery & Development
Price on request
Request a quote for more information about this service.
Drug Development
Price on request
Request a quote for more information about this service.
Environmental & Geological Sciences
Price on request
Request a quote for more information about this service.
Environmental Science
Price on request
Request a quote for more information about this service.
Water Quality Monitoring
Price on request
Request a quote for more information about this service.
Ecotoxicology and Exposure Assessment
Price on request
Request a quote for more information about this service.
Medical Devices & Diagnostics
Price on request
Request a quote for more information about this service.
Ask A Question Find what you're looking for? If not, you can ask this lab a question:

SGS Pharmaceutical Services has not received any ratings.

Be the first to endorse SGS Pharmaceutical Services

Endorse this lab