Founded in 2008, Advanced Analytical Testing Laboratories is a GMP compliant, FDA regulated contract testing facility. It provides Analytical Testing, Research and Development and Consulting Services to Pharmaceutical, Biotechnology and other FDA regulated industries at cost effective prices.
We specialize in Raw Material, Finished Product, Method Development and Validation Testing. All work completed by the laboratory undergoes a stringent Quality Control and Quality Assurance review process prior to final report release. As a full service laboratory, AATL’s entire staff is committed to meeting quality and testing requirements with accuracy and quick turnaround times.
As leaders in our profession, we strive to deliver services of the highest quality that fully satisfy the expectations of our Clients. Protecting our Clients’ interests is the foundation of our business along with Compliance to all Regulations that govern us. Quality is a corporate commitment within Advanced Analytical Testing Laboratories (AATL) and is the individual responsibility of all employees. We project and live up to the image of integrity and professionalism.
Need to move projects forward but just can’t seem to find the time to get all the paperwork done? Let Advanced Analytical Testing Laboratories consulting services help. We've assembled a team of individuals with years of pharmaceutical industry experience to provide you with the knowledge - backed by laboratory capability and capacity to drive your projects forward. Our team has a wide array of pharmaceutical experience and expertise.
Here’s a partial list of what we can provide:
Analytical method validation protocols
Analytical method transfer protocols
Cleaning validation protocols with respect to analytical methods and swabbing techniques
Stability study protocols
Lot Release Testing
Advanced Analytical Testing Laboratories offers a full range of services to support Quality Control and release testing to ensure the safety and efficacy of your product.
Our cGMP compliance ensures that the testing we perform for you will be acceptable to FDA, EMEA, and other regulatory authorities. Our experienced scientists can design a Lot Release Program to met your needs as well as perform assay development and validation.
Analytical services are available to characterize your products as well as confirm Identity, Purity and Strength. A full range of services is also available to ensure the Lot meets label claim requirements.
The Pharmaceutical Chemistry Group at Advanced Analytical Testing laboratories provides high quality analytical data delivered on time. Our experienced chemists along with state-of-the art instrumentation will satisfy all your analytical needs. Our internal QA group routinely audits each of our areas for strict compliance with cGMP requirements.
Our client interface team can meet your needs – regardless of whether you need results in two weeks or overnight. We have the size and capacity to meet the most demanding turnaround time requirements.
All this, backed by experience in testing all types of raw materials, utilities, solid dosage forms and immediate release products, to controlled release products, liquids, suspensions and niche formulations such as aerosol and transdermal products.
Our chemistry service listing includes:
Analytical Method Development/Validation
Raw Materials Testing
Stability Testing and Stability Storage
Comparator Product Testing
Marketed Product Release Testing
Commercial Product Retain Program
Support for Stability
AATL offers comprehensive services to support the stability testing of your products. Our stability program can assist you in determining the appropriate storage conditions and shelf life of your sensitive product. Our laboratories and storage facilities are fully compliant with current Good Manufacturing Practice requirements.
Features of our stability program include:
Analytical Method Development and Validation. Our experienced scientists develop stability-indicating methods specific to your product and conduct validation of method parameters, including accuracy, precision, linearity, recovery and ruggedness, following regulatory and ICH guidelines
Analytical Testing. A wide range of assays to characterize your biological product and assess degradation and impurities
Storage Facilities. Stability samples are stored in our secure stability chambers
Protocol Development and Study Management
Our stability staff provides comprehensive study management services, including:
Study design and development of protocols that ensure your studies are conducted in compliance with ICH guidelines
Client-dedicated stability project managers oversee all aspects of your study throughout its execution at our facility
Advanced Analytical Testing Laboratory provides complete Trending Reports on Validation and Routine Samples when required by its Clients.
AATL will track results for all samples related to a validation or a particular study and will trend them for easy understanding of the results.
The trending reports helps find problems or potential problems associated with either routine process batches or validation processes.
Method Development and Validation per USP <1225> and ICH
Method Development and Validation services are offered for residual solvents testing for individual APIs and drug products, API and preservative assays in drug products, and impurities in APIs and drug products. These services are also offered for materials and testing requirements that are not covered by compendia specifications.
Validation of methods developed by Advanced Analytical Testing Laboratories is performed according to the requirements in USP general chapter <1225>. Validation studies include determination of the linearity, range, accuracy, repeatability, and intermediate precision of the method. For residual solvents and impurities methods, validation also includes determination of the limit of detection and the limit of quantitation.
Advanced Analytical Testing Laboratory provides complete USP Container Testing Expertise
Advanced Analytical Testing Labs provides comprehensive analysis and qualifications of all packaging components for pharmaceutical containers. Our combined laboratory staff brings over 50 years of experience and expertise to each container test requested.
Container types routinely tested include:
HDPE & LDPE
Glass Bottles and Syringes (Types I, II, III, NP)
PET & PETG
Plastic & Laminate Pouches
Single Unit Dose and Unit Dose Blister Cards
Container test procedures include USP, EP and JP. Common USP procedures are as follows:
USP <661> Containers
USP <661> PhysioChemical for Plastics
USP <671> Containers – Permeation
USP <381> Elastomeric Closures
Quality Control Dimension Testing
In addition, the laboratory will customize all container testing procedures to client specific protocols.
Stability Storage and Testing Program
Advanced Analytical Testing Laboratory is equipped with Stability Chambers for storage of samples for Expiration Dating. The chambers are monitored on a continuous basis. AATL follows ICH and USP guidelines for Sample Stability.
AATL stores samples and also provides testing on these samples at the specified time intervals when test services are required by its Clients.
AATL also provides its Clients with executive summary reports of the stability studies from Time 0 to the end of the stability time period.
In-Process/ Finished Product Testing
Whenever you initiate a new process, change a piece of equipment, or adjust your product formulation, you need to re-validate your process. Our prompt in-process testing will ensure that you experience no delays in manufacturing your product and getting it to the market.
By working closely with you, we are able to schedule your time-sensitive in-process testing and lot release testing projects just days in advance – delivering rapid turnaround and, in many cases, even same-day analytical service.
Complete Monograph Testing of Raw Materials per USP, EP and JP
Advanced Analytical Testing Laboratory has a comprehensive analytical laboratory that offers USP-NF (United States Pharmacopeias- National Formulary), EP (European Pharmacopeia) and JP (Japanese Pharmacopeia) Monograph testing for all raw materials.
AATL provides complete Raw Material testing for Qualification of Active Pharmaceutical Ingredients (API) and Excipients.
AATL provides Residual Solvent Testing per current USP <467> and Client Specific Validated method for Raw Material and Finished Product release as required by USP.
AATL Laboratory Instrumentation includes:
HPLC System with Autosampler for Potency Assays and Impurities
GC System with Autosampler and Headspace unit for Potency Assays, Residual Solvents and Impurities
Fourier Transmittance Infra Red (FTIR) Spectrophotometer for Identifications on Raw Materials
Ultra Violet and Visible (UV-VIS) Spectrophotometer for Identifications and Quantitative Assays
Dissolution Apparatus for Solid Dosage Drug Release
Refractometer for Refractive Index on Raw Materials
Total Organic Carbon (TOC) Analyzer for Total Organic Carbon Analysis
Conductivity Meter for Conductivity Measurements
pH Meter for pH Measurements
Melting Point Apparatus for Melting Range Measurements
Polarimeter for Specific Rotation and Optical Rotation Measurements
Brookefield and Kinematic Viscometers for Viscosity Measurements
Karl Fischer Titrators for Water by Karl Fischer Measurements
Wet Chemistry Testing
Advanced Analytical Testing Laboratory has a comprehensive analytical laboratory that provides complete Wet Chemistry Testing.
Common Compendial tests completed by the laboratory include:
• Heavy Metals
• Loss on Drying
• Residue on Ignition
• Total Organic Carbon
• Residual Solvents
• Water Content
• Congealing Temperature
• Sulphated Ash
• Identification (Wet Chemistry, FTIR, UV-VIS, TLC)
• Chloride and Sulfate
• Carbonizable Substances
• Nitrogen Determination
• Bulk and Tap Density
• Specific Gravity
• Loss on Ignition
• Melting Range
• Particulate Matter
• Minimum Fill
• Refractive Index
• Specific and Optical Rotation
• Plus Many Other USP, EP & JP General Chapter Tests
Gas Testing per USP, EP and JP
Advanced Analytical Testing Laboratory provides complete Gas Testing. Until recently, medical gas testing was routinely assigned to industrial testing labs (non-GMP) that tend to serve a variety of industries. In June 2003, the FDA issued a new Guidance Document on medical gas usage. Since then the pharmaceutical industry has begun the process of qualifying gases they routinely use in production operations.
To meet these emerging needs, Advanced Analytical Testing Labs has invested in the technology and personnel required to offer comprehensive gas testing services for pharmaceutical and biotechnology clients. Commonly tested gases include:
• USP / EP Nitrogen
• USP / EP Carbon Dioxide
• USP / EP Oxygen
• USP/ EP Compressed Air
Advanced Analytical Testing Labs quality assurance team will work with clients to develop gas testing protocols and validation reports to insure your company meets FDA requirements for medical gas usage.
Advanced Analytical Testing Laboratory has a comprehensive analytical laboratory that offers complete Water Testing services to comply with Purified Water, Water for Irrigation, Water for Injection, Water for Inhalation, Water for Hemodialysis and Bacteriostatic Water for Injection based on USP-NF (United States Pharmacopeias- National Formulary), EP (European Pharmacopeia) and JP (Japanese Pharmacopeia) Monograph testing for all different grades of water.
Common Water Testing Includes:
Total Organic Carbon (TOC)
Residue on Evaporation
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