Eyqmr36fquay8bhng8rl logo sgs

SGS Medical Devices

US

No matter what the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market quickly whilst ensuring compliance with the required regulations and standards.

As the world’s largest inspection, verification, testing and certification company, we provide clients with a market-leading, global network of medical device offices, laboratories and experts. Operating in over 35 countries, we offer global and local solutions to meet your certification, testing, training and audit requirements. We offer virtually every global approval you need now or will need in the future.

SGS Medical Devices has not listed any services.

Ask A Question Find what you're looking for? If not, you can ask this lab a question:
Thermal Analysis Services
Price on request

SGS can perform thermal analysis by TGA and DSC of polymeric components of medical devices.
TGA can be used to determine composition of complex mixtures of polymers. TGA calculates the weight loss of a material at elevated temperatures.

DSC is used in identification of materials and potential change in transition states... Show more »

SGS can perform thermal analysis by TGA and DSC of polymeric components of medical devices.
TGA can be used to determine composition of complex mixtures of polymers. TGA calculates the weight loss of a material at elevated temperatures.

DSC is used in identification of materials and potential change in transition states that may occur throughout the temperature range of use of the device.

TECHNIQUES/TESTS

  • Polymer testing by TGA and DSC
« Show less
TA Instruments Discovery
TA Instruments Q20
DSC
TGA
Sterility Testing
Price on request

Sterility testing of products and/or biological indicators (i.e. spore strips) exposed to a sterilization process is an important part of all sterility assurance programs. Most manufacturers of EO sterilized medical devices monitor their validated EO sterilization loads with B. atrophaeus spore strips and release their products... Show more »

Sterility testing of products and/or biological indicators (i.e. spore strips) exposed to a sterilization process is an important part of all sterility assurance programs. Most manufacturers of EO sterilized medical devices monitor their validated EO sterilization loads with B. atrophaeus spore strips and release their products for distribution based on negative sterility test results of the spore strips. The spore strips may be placed inside or outside the product depending on the parameters developed during the cycle validation. The spore strips should be distributed in locations throughout the sterilization chamber and product load. A positive control (i.e. unprocessed spore strip) should be included with all spore strip sterility tests. These routine sterility tests must be supplemented periodically with more extensive cycle validations.

Routine lot release of terminally sterilized medical devices by means of end product sterility testing is not recommended for several reasons (For devices sterilized by radiation see AAMI/ISO Dose Audit information sheet). The bioburden of most medical devices is generally a lesser challenge to the sterilization process than biological indicators and overkill cannot be demonstrated. Statistically, the probability that a sterility test of 20 or 40 product samples will detect non-sterile samples among a much larger number of products is very limited. Also, it is generally recognized that the process of sterility testing has a significantly lower sterility assurance level than most validated terminal sterilization processes. However, end product sterility testing of medical devices is occasionally performed as part of investigations or to support other information in making a lot release decision.

TECHNIQUES/TESTS

  • Spore Strips Only
    • Used for devices sterilized by steam or ETO in a validated cycle.
  • Product with Spore Strips
    • Used for fractional and half cycles in steam and ETO sterilization validations.
  • Product Only – Direct Transfer or Fluid Path
    • Entire devices or portions of devices are rinsed with or submerged in Soybean Casein Digest Medium and Fluid Thioglycolate Medium
  • Inoculated Product
    • Product samples which have been inoculated with microorganism that is resistant to the sterilization process are used as biological indicators.
« Show less
Spore Strips
EtO Sterilization
Direct Transfer
Fluid Path
Medical Device Testing
Price on request

Stability testing of medical devices is also known as expiration dating or accelerated aging studies. An accelerated aging study is used to support the assignment of an expiration date to a sterile medical device. A real time aging study, with additional products stored at room temperature, must be used to support the assignment... Show more »

Stability testing of medical devices is also known as expiration dating or accelerated aging studies. An accelerated aging study is used to support the assignment of an expiration date to a sterile medical device. A real time aging study, with additional products stored at room temperature, must be used to support the assignment of an expiration dating claim that is based on an accelerated aging study. Accelerated aging is a process in which products and packaging are stored in an environmental chamber at an elevated temperature to simulate a longer period of real time aging. SGS generally used the following sequence to simulate one year of aging at a room temperature of 23°C:

20-21 days at 55°C with 75%R.H.
24 hours at -25°C to -10°C (optional)
20-21 days at 55°C with <20%R.H.

Following aging, the test samples are subjected to Package Distribution Simulation according to ASTM D4169, Standard Practice for Performance Testing of Shipping Containers and Systems to simulate stresses that could occur during shipment of the product. The packaging and product can then be subjected to a variety of tests to evaluate the effects of the aging and shipping processes. For packaging, recommended testing options include seal strength and package integrity by dye penetration and/or microbial challenge. For products, testing should include applicable physical performance testing and visual comparison to products that have not been aged.

Accelerated aging studies are normally conducted in accordance with a written protocol. Products that have been exposed to a validated sterilization process should be used in these studies. A typical study includes testing of samples after several aging intervals (eg. 1, 3, and 5 year equivalency). The protocol specifies the aging intervals and the tests to be performed at each interval. The sample requirements are based on the number of aging intervals and the tests required after each interval.

SGS can provide accelerated aging storage services when other testing is not required. Alternate aging conditions are also available.

SGS has world-class expertise in medical device stability analysis. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients.

TECHNIQUES/TESTS

  • Accelerated Aging
  • Real Time Aging
  • ASTM Distribution Simulation
  • Seal Peel Test
  • Package Integrity by Microbial Challenge
  • Package Integrity by Dye Penetration
  • Protocol
« Show less
Microbial Challenge
Package Integrity
Accelerated Aging
Real Time Aging
ASTM Distribution Simulation
Seal Peel Test
Dye Penetration
Cleaning Validation Services
Price on request

To address regulatory and liability concerns, manufacturers of medical devices that are intended for reuse and sterilization in health care facilities must provide specific cleaning, disinfection and/or sterilization instructions to their customers.  To insure that reliable cleaning, disinfection and or sterilization is achieved... Show more »

To address regulatory and liability concerns, manufacturers of medical devices that are intended for reuse and sterilization in health care facilities must provide specific cleaning, disinfection and/or sterilization instructions to their customers.  To insure that reliable cleaning, disinfection and or sterilization is achieved the instructions must be validated.  AAMI TIR 12, ANSI/AAMI ST81, ANSI/AAMI ST79, AAMI TIR 30 and FDA guidance documents provide detailed information on what testing should be performed to complete the validation studies. 

SGS can simulate most conventional hospital cleaning (manual), disinfection and sterilization procedures.  SGS can perform testing according to your protocol or help prepare a protocol in consultation with you.

Cleaning study validations involve contaminating the test samples with organism and a test soil to simulate post use conditions.  Once dried, the samples undergo the provided/purposed cleaning procedures typically performed by two different analysts.  The samples are then extracted and tested for residual organism and protein.  Testing is in accordance with AAMI TIR 12 and TIR 30.

Disinfection study validations involve inoculating test samples with organism(s) and allowing the inoculum to dry on the samples.  The provided/purposed disinfection procedure is performed on each sample.  The samples are then extracted and tested for any residual challenge organism on the samples.  High level, intermediate level and low level disinfection can be performed.  Testing is in accordance with AAMI TIR 12 and AAMI TIR 30.

Steam study validation involves contaminating test samples with a Geobacillus stearothermophilus spore suspension at a level of 106 CFU/device.  The samples are allowed to dry and are then subjected to the specified autoclave parameters.  Post sterilization the samples are tested for sterility.  Tests to determine the recommended dry time are also required.  Samples are subjected to the autoclave cycle with dry time and are then inspected for the presence of moisture. Testing is in accordance with ANSI/AAMI ST 79, AAMI TIR 12 and ANSI/AAMI ST 81.
SGS can simulate most conventional hospital cleaning and sterilization procedures. SGS can perform testing according to your protocol or prepare a protocol in consultation with you.

SGS has world-class expertise in reusable device studies. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients.

TESTS

  • Protocols
  • Cleaning Validation Studies
  • Disinfection Validation Studies
  • Sterilization Validation Studies including Ethylene Oxide, Steam Sterilization, Liquid Chemical Sterilization, and Dry Heat Sterilization and Depyrogenation
« Show less
Ethylene Oxide
AAMI TIR 12
ANSI/AAMI ST81
ANSI/AAMI ST79
AAMI TIR 30
FDA guidance
Cleaning Study Validations
Disinfection Study Validations
Steam Study Validations
Geobacillus stearothermophilus
Reusable Device Studies
Steam Sterilization
Liquid Chemical Sterilization
Dry Heat Sterilization
Depyrogenation
Electron-Beam (E-Beam) Radiation Sterilization
Price on request

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it... Show more »

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it effectively and reliably kills any organisms that may be present on the pre-sterilized product. By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO.

Several sterilization validation methods are described in ANSI/AAMI/ISO 11137-02 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose for validation of the radiation dose used to sterilize a medical device. All of the methods described below use product bioburden enumeration and a bioburden organism resistance sterility test, which is referred to as the verification dose resistance experiment. The most appropriate methodology is selected based on the projected production schedule and size, as well as the expected bioburden levels of the product. The most commonly used methods are:

ANSI/AAMI/ISO VDmax Methods

The VDmax methods are used to establish 15 or 25 kGy as the minimum sterilization dose for products manufactured frequently or infrequently in large or small batches. VDmax15 is limited to products with bioburden of <1.5 cfu, while VDmax25 is limited to products with a bioburden of >1000 cfu. Alternative FDmax values from 15 kGy to 35 kGy are also available (AAMI/TIR 33:2006).

ANSI/AAM/ISO Method 1

Method 1 is used to determine a product specific sterilization dose for products manufactured frequently or infrequently in large or small batches. This method is applicable to products with all levels of bioburden.

ANSI/AAM/ISO Method 2

Method 2 is used when a product fails the routine method 1 testing. It is reserved for difficult to sterilize product. By using incremental doses on three different lots starting at 0 kGy and going up to 18 kGy in increments of 2 kGy the appropriate sterilization dose is obtained through evaluation of the results. Based on these calculations a verification dose is obtained and a set of 100 products are tested for validation.

SGS has world-class expertise in radiation sterilization analysis. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients.

TECHNIQUES/TESTS

  • Sterilization Validation Protocol
    • A protocol outlining the overall validation requirements must be generated for the initial validation. It should define the product family and specify the test procedures to be used. Please submit one sample for evaluation purposes.
  • Sample Item Portion (SIP) Preparation
    • It may be necessary to use a simulated scaled down version of the product for bioburden and the verification dose resistance experiment for some large or complex devices.
  • Bioburden Method Recovery Validation
    • This testing ensures that the routine bioburden method is effective in recovering microorganisms. It will determine if it is appropriate to apply a recovery factor to the routine bioburden test results.
  • Repetitive (Exhaustive) Recovery Method
    • A minimum of 3 non sterile samples are required, 5 are recommended.
  • Product Inoculation (Simulated) Recovery Method
    • A minimum of 3 Sterile samples are required, 5 are recommended.
  • Screening for the Release of Adverse Substances
    • 9 Sterile samples are required.
  • Bioburden Enumeration – Determination of the bioburden level on the product. For most products, aerobic bacteria and fungi levels are appropriate. Sample amounts are method dependent.
  • Dose Calculation – A determination of the verification dose based on the bioburden levels and selected method.
  • Sterility Suitability Testing – Testing to verify the product does not leach anything into the media that would be bacteriostatic or fungistatic, causing a false negative result. 3 sterile samples are required to validate the AAMI/ISO test, 6 are required if the USP sterility test validation is required also.
  • Verification Dose Resistance Experiment – Sterility test of products irradiated at a defined dose to determine if any of the organisms that are part of the product bioburden are unusually resistant. Sample requirements are method specific.
  • Dose Auditing -10 non sterile samples are submitting for bioburden monitoring and samples from the same lot are submitted for the verification dose sterility testing quarterly.
« Show less
ANSI/AAMI/ISO 11137-02
ANSI/AAMI/ISO VDmax Methods
VDmax
ANSI/AAMI/ISO Method 1
ANSI/AAMI/ISO Method 2
Sterilization Validation Protocol
Sample Item Portion (SIP) Preparation
Bioburden Method Recovery Validation
Repetitive (Exhaustive) Recovery Method
Product Inoculation (Simulated) Recovery Method
Screening for Release of Adverse Substances
Bioburden Enumeration
Dose Calculation
Sterility Suitability Testing
Verification Dose Resistance Experiment
Dose Auditing
Gamma Irradiation Sterilization
Price on request

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it... Show more »

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it effectively and reliably kills any organisms that may be present on the pre-sterilized product. By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO.

Several sterilization validation methods are described in ANSI/AAMI/ISO 11137-02 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose for validation of the radiation dose used to sterilize a medical device. All of the methods described below use product bioburden enumeration and a bioburden organism resistance sterility test, which is referred to as the verification dose resistance experiment. The most appropriate methodology is selected based on the projected production schedule and size, as well as the expected bioburden levels of the product. The most commonly used methods are:

ANSI/AAMI/ISO VDmax Methods

The VDmax methods are used to establish 15 or 25 kGy as the minimum sterilization dose for products manufactured frequently or infrequently in large or small batches. VDmax15 is limited to products with bioburden of <1.5 cfu, while VDmax25 is limited to products with a bioburden of >1000 cfu. Alternative FDmax values from 15 kGy to 35 kGy are also available (AAMI/TIR 33:2006).

ANSI/AAM/ISO Method 1

Method 1 is used to determine a product specific sterilization dose for products manufactured frequently or infrequently in large or small batches. This method is applicable to products with all levels of bioburden.

ANSI/AAM/ISO Method 2

Method 2 is used when a product fails the routine method 1 testing. It is reserved for difficult to sterilize product. By using incremental doses on three different lots starting at 0 kGy and going up to 18 kGy in increments of 2 kGy the appropriate sterilization dose is obtained through evaluation of the results. Based on these calculations a verification dose is obtained and a set of 100 products are tested for validation.

SGS has world-class expertise in radiation sterilization analysis. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients.

TECHNIQUES/TESTS

  • Sterilization Validation Protocol
    • A protocol outlining the overall validation requirements must be generated for the initial validation. It should define the product family and specify the test procedures to be used. Please submit one sample for evaluation purposes.
  • Sample Item Portion (SIP) Preparation
    • It may be necessary to use a simulated scaled down version of the product for bioburden and the verification dose resistance experiment for some large or complex devices.
  • Bioburden Method Recovery Validation
    • This testing ensures that the routine bioburden method is effective in recovering microorganisms. It will determine if it is appropriate to apply a recovery factor to the routine bioburden test results.
  • Repetitive (Exhaustive) Recovery Method
    • A minimum of 3 non sterile samples are required, 5 are recommended.
  • Product Inoculation (Simulated) Recovery Method
    • A minimum of 3 Sterile samples are required, 5 are recommended.
  • Screening for the Release of Adverse Substances
    • 9 Sterile samples are required.
  • Bioburden Enumeration – Determination of the bioburden level on the product. For most products, aerobic bacteria and fungi levels are appropriate. Sample amounts are method dependent.
  • Dose Calculation – A determination of the verification dose based on the bioburden levels and selected method.
  • Sterility Suitability Testing – Testing to verify the product does not leach anything into the media that would be bacteriostatic or fungistatic, causing a false negative result. 3 sterile samples are required to validate the AAMI/ISO test, 6 are required if the USP sterility test validation is required also.
  • Verification Dose Resistance Experiment – Sterility test of products irradiated at a defined dose to determine if any of the organisms that are part of the product bioburden are unusually resistant. Sample requirements are method specific.
  • Dose Auditing -10 non sterile samples are submitting for bioburden monitoring and samples from the same lot are submitted for the verification dose sterility testing quarterly.
« Show less
ANSI/AAMI/ISO 11137-02
ANSI/AAMI/ISO VDmax Methods
VDmax
ANSI/AAMI/ISO Method 1
ANSI/AAMI/ISO Method 2
Sterilization Validation Protocol
Sample Item Portion (SIP) Preparation
Bioburden Method Recovery Validation
Repetitive (Exhaustive) Recovery Method
Product Inoculation (Simulated) Recovery Method
Screening for Release of Adverse Substances
Bioburden Enumeration
Dose Calculation
Sterility Suitability Testing
Verification Dose Resistance Experiment
Dose Auditing
Polymer Characterization
Price on request

Proper polymer selection for your medical device can increase or extend the performance of your device. Compatibility issues of polymers with drug formulation should also be considered when designing or choosing a device.

SGS can help confirm the composition of materials used in your device.

TECHNIQUES/TESTS

-... Show more »

Proper polymer selection for your medical device can increase or extend the performance of your device. Compatibility issues of polymers with drug formulation should also be considered when designing or choosing a device.

SGS can help confirm the composition of materials used in your device.

TECHNIQUES/TESTS

  • Physicochemical testing
    • Buffering capacity, non-volatile residues, heavy metals
  • Polymer testing by TGA, DSC, and IR
« Show less
Heavy Metals
Buffering Capacity
IR
DSC
TGA
Physiochemical Testing
Non-volatile Residues
Polymer Testing
Extractable and Leachable Testing
Price on request

The assessment of extractables and leachables (E&L) in pharmaceutical products and medical devices is a critical step in drug product/medical device development. As pharmaceutical containers, closure systems, manufacturing or storage equipment and other materials that come in contact with the drug product can be a potential... Show more »

The assessment of extractables and leachables (E&L) in pharmaceutical products and medical devices is a critical step in drug product/medical device development. As pharmaceutical containers, closure systems, manufacturing or storage equipment and other materials that come in contact with the drug product can be a potential source of compounds of toxicological concern. Regulatory authorities are requiring risk assessments associated with appropriate E&L studies.

SGS Life Science Services in New Jersey designs and performs E&L studies that will satisfy regulatory authorities, such as the FDA and EMA, as well as adhere to PQRI, BPOG and BPSA recommendations. Our facilities are fully GMP compliant facilities registered and inspected by FDA and accredited with International Organization for Standardization (ISO). The majority of technical staff on our E&L team hold advanced degrees (M.S., Ph.D.) and have years of experience on E&L study designs, analytical instrumentation and structure elucidation expertise.

Extraction/Sample Preparation Techniques:

  • Extraction methodologies-reflux, soxhelt, sonication and agitation
  • Non-volatile residue by gravimetric and FTIR
  • Total organic carbon by TOC analyzer
  • Volatile organic compounds by Headspace-GC-MS/FID
  • Semi-volatile organic compounds by GC-MS/FID
  • Non-volatile organic compounds by LC-MS/DAD
  • Trace metals and Inorganic elements by ICP-OES or ICP-MS

State-of-the-art Analytical Instruments:

  • Gas chromatography systems with headspace samplers and mass spectrometers (GC-MS/FID)
  • UPLC systems with PDA and QDA detectors and mass spectrometers (LC-MS/DAD)
  • ICP-OES and ICP-MS systems

SGS Experience:

  • Orally inhaled and nasal drug products (OINDP)
  • Parenteral and ophthalmic drug products (PODP)
  • Pre-filled syringes(PFS)
  • Vials and Bottles (Glass, HDPE, LDPE, etc.)
  • Rubber Stoppers/Caps
  • Tubes (creams and ointments)
  • Plastic Bags (IV bags, bioprocess bags, liner bags, etc.)
  • Filters (cartridges and capsules)
  • Medical devices (tubing, sheeting, pump, etc.)
  • Label Ink Migration through transdermal patch, bottles, tubes, and PFS
  • Primary/Secondary container closure systems
« Show less
Waters UPLC
Agilent GC
Agilent ICP-OES
Agilent ICP-MS
Gravimetric
HS/GC/MS
GC-FID/MS
FTIR
LC-DAD/MS
ICP
Glass vials
Stoppers
Pre-filled syringes
Filters
Cartridges
Medical devices
Patch
Bottles
Ethylene Oxide Sterilization
Price on request

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it... Show more »

A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas or gamma or electron beam radiation. The sterilization process must be validated for each product to verify that it effectively and reliably kills any organisms that may be present on the pre-sterilized product. By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO.

The most commonly used method to validate ethylene oxide cycles used in the sterilization of medical devices is the overkill method. The overkill method (AAMI/ISO 11135 Method C) is based on demonstrating that the sterilization of a microbial challenge (biological indicator) exceeds the challenge posed by the bioburden of the product.

SGS has world-class expertise in ethylene oxide sterilization analysis. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients

TESTS

  • Protocol
  • Sterility Validation
  • Bioburden Validation
  • Bioburden Enumeration
  • Biological Indicator Testing
  • Sterility Testing
  • Ethylene Oxide Residuals
« Show less
Headspace
Ethylene Oxide
Ethylene Glycol
AAMI/ISO
EtO
Microbial Challenge
Sterility Testing
Bioburden Enumeration
Sterility Validation
Bioburden Validation
Biological Indicator Testing
BI
Pharmaceutical Formulation
Price on request

Drug Compatibility Studies

Choosing the correct drug formulation is vital when using in conjunction with a medical device. SGS has experience with extractable and leachable testing to confirm that the formulation chosen does not cause toxic compounds to be released from the device tubing, plastics, glass, rubber or metals.... Show more »

Drug Compatibility Studies

Choosing the correct drug formulation is vital when using in conjunction with a medical device. SGS has experience with extractable and leachable testing to confirm that the formulation chosen does not cause toxic compounds to be released from the device tubing, plastics, glass, rubber or metals. The E&L group has extensive experience with testing tubing, filters, and prefilled syringes, to name a few.

These formulations can also affect the performance of the device itself. Corrosion caused by acid, bases, alcohols or other components in the formulation can cause premature failure in some medical devices. SGS will can quantitate components in the formulation and check pH.

The selection of the proper materials to be used with your formulation should be taken into consideration when designing or choosing a device to be used in conjunction with a drug formulation.
SGS can help confirm the composition of materials used in your device.

TECHNIQUES/TESTS

  • E&L studies
    • Volatile, semi-volatile, and non-volatile substances, heavy metals
  • Analytical techniques such as HPLC to determine individual components
  • Physicochemical testing
    • Buffering capacity, non-volatile residues, heavy metals and pH
  • Polymer testing by TGA, DSC, and IR
« Show less
Bioburden Testing
Price on request

Bioburden is the population of microorganisms on a raw material, product component or finished medical device just prior to sterilization. For finished medical devices, the bioburden test data is used to establish parameters for an effective sterilization process. To insure the ongoing safety of the sterilization process, it is... Show more »

Bioburden is the population of microorganisms on a raw material, product component or finished medical device just prior to sterilization. For finished medical devices, the bioburden test data is used to establish parameters for an effective sterilization process. To insure the ongoing safety of the sterilization process, it is necessary to verify that the bioburden level remains consistent over time. There are two important aspects of product bioburden control – maintaining consistency from lot to lot and avoiding spikes within a single lot. A bioburden spike occurs when the bioburden for an individual product is two or more times greater than the group average. A significant increase in the device bioburden would reduce the sterility assurance level of the sterilization process.

For new medical devices, ten randomly selected samples from three separate newly manufactured lots should be tested for bioburden. It is useful to track samples by date and time of assembly or packaging to determine when and where any inconsistencies may be occurring. After initial data is generated, bioburden tests should be conducted monthly to quarterly, depending on the frequency and volume of production, as part of an ongoing environmental monitoring program. It is also important to check bioburden levels whenever any changes are made in packaging locations, manufacturing processes, raw material vendors or personnel involved with production. If bioburden data increases significantly or shows extreme variability, the manufacturing process should be investigated so that corrective measures can be implemented.

Bioburden studies are also used to monitor microorganism levels on materials that could affect the bioburden of the finished device, such as product components, manufacturing fluids and product packaging. The bioburden test data may provide useful information in the investigation of bioburden spikes and dose audit failures. Bioburden testing can also be used as a material qualifications tool. For additional information refer to Sterilization of medical devices – Microbiological methods, Part 3: Guidance on evaluation and interpretation of bioburden data (ANSI/AAMI/ISO 11737-3:2004).

To perform a bioburden test, a sample is aseptically transferred to an appropriate volume of extraction fluid and then mechanically agitated to remove microorganisms. Membrane filtration is the preferred method for the culturing and microbial enumeration of the extraction fluid. SGS uses this method for products with filterable extraction fluid. When the extraction fluid cannot be filtered, the plate count method is used. Bioburden results are reported on individual samples showing total aerobic count with a breakdown of bacteria and fungi. Anaerobic bioburden and heatshocking methods for enumeration of spores are also available.

TECHNIQUES/TESTS

  • Bioburden Test Method Validation – Recovery Study
  • Bioburden Test Method Validation – Screening for the Release of Adverse Substances
  • Bioburden - Total Aerobic Bacteria and Fungi
  • Bioburden – Total Anaerobic Bacteria
  • Bioburden – Total Aerobic Spores
« Show less
Microbial Limits (USP <61>)
Bioburden
Membrane Filtration
Pour Plate
ISO
Stomecher
Screening for Release of Adverse Substances
Class 5
ANSI/AAMI/ISO
Recovery Study
Bioburden Test Method Validation
Total Aerobic Bacteria and Fungi
Total Anaerobic Bacteria
Total Aerobic Spores
Raw Material Testing
Price on request

Testing the materials that comprise your medical devices is critical to ensure the best performance and safety of your product. SGS can help with all aspects of materials testing from microbiological testing to chemical properties to extractable and leachable studies. Let SGS be your one-stop shop for materials testing of your... Show more »

Testing the materials that comprise your medical devices is critical to ensure the best performance and safety of your product. SGS can help with all aspects of materials testing from microbiological testing to chemical properties to extractable and leachable studies. Let SGS be your one-stop shop for materials testing of your medical devices.

TECHNIQUES/TESTS

  • Microbiological Tests
    • Cytotoxicity, Bioburden, Endotoxin, Sterility and cleaning studies
  • Biocompatibility studies
    • In vitro testing of biocompatibility
  • Physicochemical testing
    • Buffering capacity, non-volatile residues, heavy metals
  • Polymer testing by TGA, DSC, and IR
  • E&L studies
    • Volatile, semi-volatile, and non-volatile substances, heavy metals
« Show less
endotoxin
Cytotoxicity
Bioburden
Heavy Metals
Extractables and Leachables
Cleaning Studies
Buffering Capacity
IR
DSC
TGA
Non-volatile Residues
Polymer Testing
Sterility
Biocompatibility Studies
Volatile Substances
Semi-Volatile Substances
Non-Volatile Substances
Cytotoxicity Assays
Price on request

Cell culture assays are used to assess the biocompatibility of a material or extract through the use of isolated cells in vitro. These techniques are useful in evaluating the toxicity or irritancy potential of materials and chemicals. They provide an excellent way to screen materials prior to in vivo tests.

There are three... Show more »

Cell culture assays are used to assess the biocompatibility of a material or extract through the use of isolated cells in vitro. These techniques are useful in evaluating the toxicity or irritancy potential of materials and chemicals. They provide an excellent way to screen materials prior to in vivo tests.

There are three USP cytotoxicity tests commonly used:

The Direct Contact procedure is recommended for low-density materials, such as contact lens polymers. In this method, a piece of test material is placed directly onto cells growing on culture medium. The cells are then incubated. During incubation, leachable chemicals in the test material can diffuse into the culture medium and contact the cell layer. Reactivity of the test sample is indicated by malformation, degeneration and lysis of cells around the test material.
The Agar Diffusion assay is appropriate for high-density materials, such as elastomeric closures. In this method, a thin layer of nutrient-supplemented agar is placed over the cultured cells. The test material (or an extract of the test material dried on filter paper) is placed on top of the agar layer and the cells are incubated. A zone of malformed, degenerated or lysed cells under and around the test material indicates cytotoxicity.

The MEM Elution assay uses different extracting media and extraction conditions to test devices according to actual use conditions or to exaggerate those conditions. Extracts can be titrated to yield a semi-quantitative measurement of cytotoxicity. After preparation, the extracts are transferred onto a layer of cells and incubated. Following incubation, the cells are examined microscopically for malformation, degeneration and lysis of the cells. At least one type of cytotoxicity test should be performed on each component of any device.

ISO methods may also be used for cytotoxicity tests, which include the tests outlined in USP, but also include quantitative assays that rely on dilutions of sample extracts and measurement of culture viability after exposure.
SGS has world-class expertise in cytotoxicity assays. We only perform the assays using USP reference standards and are recognized as the global benchmark for quality and integrity. We are committed to providing the best services in our class to all of our clients.

TECHNIQUES/TESTS

  • Direct Contact
    • Product is placed directly on the cells.
  • Agar Diffusion
    • Product or an extract is placed on a layer of agar that is over the cells.
  • MEM Elution
    • An extract is placed directly on the cells.
  • Quantitative Methods
    • Following one of the methods above, a viability staining technique is used to measure the level of cell viability.
« Show less
Cytotoxicity
MEM Elution
Direct Contact
Agarose Overlay
Facility Environmental Monitoring
Price on request

Medical device manufacturers use microbial environmental monitoring programs to evaluate the effectiveness of cleaning and disinfection procedures and to assess the overall microbial cleanliness of their manufacturing environment. An effective program to control microorganism levels in the manufacturing environment is essential to... Show more »

Medical device manufacturers use microbial environmental monitoring programs to evaluate the effectiveness of cleaning and disinfection procedures and to assess the overall microbial cleanliness of their manufacturing environment. An effective program to control microorganism levels in the manufacturing environment is essential to minimize the bioburden on the medical device being manufactured and reduce potential for bioburden spikes. Spikes in the bioburden of finished medical devices can cause a reduction in the sterility assurance level for the product.

Air and surface samples are taken during routine production operations to obtain a microbiological profile of the manufacturing environment. Observation of work practices are made during the survey. Test data and other information are evaluated to determine what actions can be taken to reduce or stabilize the bioburden of the medical product or production area. Once an intensive survey has been conducted and strategic sampling locations are determined, samples can be taken by the manufacturer’s personnel or SGS on a regular schedule. SGS can provide training on sampling as well as the necessary supplies for microbiological sampling. Exposed materials are returned to SGS for enumeration and reporting.

If any major changes are made at the facility or in the manufacturing process, or if product bioburden levels increase significantly, a re-evaluation of environmental conditions should be conducted. For additional information about environmental monitoring, refer to USP general chapter <1116> Microbiological Evaluation of Clean Rooms and other Controlled Environments or PDA TR 13 (revised 2001) Fundamentals of a Microbiological Environmental Monitoring Program.

TECHNIQUES/TESTS

  • Customized EM programs
    • EM Cleanroom Qualification
    • Assessment of New and
  • Existing Facilities Undergoing Changes
    • Consulting, On Site Assessment, Sampling and Testing
    • Qualification of Production
  • Facilities after Installation, Construction, Standstill, etc.
    • On Site Scientific Staffing – Temporary and FTE programs
    • Technical Writing Services
    • Air Sampling and Analysis
    • Active and Passive Viable Air
    • Non-Viable Air Particulates
    • Compressed Air and Gases
    • Surface Sampling and Analysis
    • Equipment Surfaces
    • Room Surfaces
    • Testing Surfaces
    • Personnel Monitoring Sampling and Analysis
    • Gowning Qualification
    • Operator Monitoring
    • Incubation and Enumeration
    • Contact Plates (RODAC)
    • Fallout Plates
    • Air Strips
    • Swabs
    • Water Testing
    • Purified Water System Validation and Routine Monitoring
    • Microbial bioburden
    • Residuals e.g. metals
    • EM Media Qualification
    • Growth Promotion
    • Neutralization Study
    • Microbial Identification of Environmental Isolates
    • Gram Staining
    • Microbial and Fungal Identification
    • EM Data Trending for Isolates and Particulates
    • Manufacturing Equipment
    • Cleaning Validation and Routine Monitoring
    • Verification of Cleaning process – Effectiveness and Impact on Product
« Show less
Biotest Hycon Air Sampler RCS
Water
Particle Size Characterization
EMD MAS-100
EMD MAS-100N
Veltek SMAP100
Biotest Hycon High Flow Touch
TOC
Bacterial Count
Cleaning Validation
Contact Plates
Air Sampler Strip
Media
Surfaces
Air
Gas
Packaging
Water Testing
Growth Promotion
USP <1117>
EM Room Qualification
Active and Passive Viable Air
Non-Viable Air Particulates
Surface Sampling and Analysis
Personnel Monitoring
Gowning Qualification
Operator Monitoring
Incubation and Enumeration
RODAC
Fallout Plates
Air Strips
Swabs
Microbial Bioburden
Residuals
EM Media Qualification
Neutralization Study
Microbial Identification
Gram Staining
Fungal Identification
Verification of Cleaning Process
Endotoxin Testing
Price on request

A pyrogen is the product of the action of heat on an organic substance and, in medical terms, is frequently described as a fever producing substance. The most potent pyrogens originate from gram negative bacteria, which are common water-borne organisms. Although not entirely accurate, the terms pyrogen and endotoxin are often... Show more »

A pyrogen is the product of the action of heat on an organic substance and, in medical terms, is frequently described as a fever producing substance. The most potent pyrogens originate from gram negative bacteria, which are common water-borne organisms. Although not entirely accurate, the terms pyrogen and endotoxin are often used interchangeably. Detection of bacterial endotoxin contamination is essential to insure the safety of certain medical devices. The Bacterial Endotoxin Test using Limulus Amebocyte Lysate (LAL) is recommended for the detection of endotoxins in medical devices. Any product that is labeled as nonpyrogenic must be tested to verify that claim. Medical devices with bloodstream or cerebrospinal fluid contact must also be tested for the presence of bacterial endotoxins.

Whether or not a device is considered pyrogenic is based on the amount of endotoxin the device contains in correlation to the accepted human tolerance of 5 endotoxin units (EU) per kilogram of body weight. Nonpyrogenic water is used to extract medical devices.

The LAL test is usually performed on a composite of the extracts of 10 samples. It is possible that one device of the composite could contain > 20 EU, when others in the composite would contain <20 EU, and the composite test would pass. The most endotoxin one device could contain, if all others in a 10 sample composite contained zero endotoxin, would be 200 EU. This is still below the human tolerance of 350 EU, based on an average human body weight of 70 kg. In a composite test, 20 EU is the average endotoxin limit for most medical devices. However, the limit for the devices which contact cerebrospinal fluid is 2.15 EU per device and in most cases the testing is performed with the minimum required extraction volume in order to demonstrate that the endotoxin level is well below the allowable endotoxin limit.

FDA had published guidelines outlining validation procedures for endotoxin testing of finished products using the LAL Test. This document is called Guideline on the Validation of the Limulus Amebocyte Lysate Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices, December 1987. A more current AAMI reference document is ANSI/AAMI ST72 Bacterial endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing, 2002.

SGS has world-class expertise in endotoxin analysis. We are recognized as the global benchmark for quality and integrity and are committed to providing the best services in our class to all of our clients.

TECHNIQUES/TESTS

  • Kinetic Chromogenic
    • Quantitative method, available by immersion or fluid path
  • Kinetic Turbidimetric
    • Quantitative method, available by immersion or fluid path
  • Gel Clot
    • Semi-Quantitative method, available by immersion or fluid path
« Show less
BioTek Microplate Reader ELX808
LAL assay
WinKQCL
Kinetic Chromogenic
Chromogenic
Gel Clot
Kinetic Turbidimetric
Turbidimetric
Bacterial Endotoxin
Lonza KQCL software and reagents
37+-1 degree C Waterbath
Depyrogenation Oven
Vortex mixer
pH Meter
Analytical Balance
Reagents from Associates of Cape Cod
ANSI/AAMI
Physical Processing
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.
Toxicology
Price on request
Request a quote for more information about this service.
Physical Analysis Methods
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.
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.
Formulation Services
Price on request
Request a quote for more information about this service.
Product Quality Control
Price on request
Request a quote for more information about this service.
Product Development, Testing, and Packaging
Price on request
Request a quote for more information about this service.
Product Testing Services
Price on request
Request a quote for more information about this service.
Laboratory and Facility Management Services
Price on request
Request a quote for more information about this service.
Engineering
Price on request
Request a quote for more information about this service.
Pharmacology & Toxicology
Price on request
Request a quote for more information about this service.
Analytical Chemistry 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.
Medical Devices & Diagnostics
Price on request
Request a quote for more information about this service.

SGS Medical Devices has not received any ratings.

Be the first to endorse SGS Medical Devices

Endorse this lab