Experience & Excellence
WELCOME TO ARL BIO PHARMA
ARL Bio Pharma provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with industry suppliers bringing excellence to the compounding industry.
- Potency Determination
- BUD and Stability Studies
- Microbial Identification
- Microbial Enumeration Tests
- Tests for Specified Organisms
- Antimicrobial Effectiveness Testing
- Particulate Matter by Light Obscuration
- Particulate Matter by Microscopy
ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
- Identification by IR
- Identification by UV
- Specific Gravity
- Water – Methods 1a, 1b, 2 and 3
- Residual Solvents
- Melting Point / Melting Range
- Loss on Drying
- Residue on Ignition
- Assay – HPLC, UV, Titration
- Heavy Metals
- USP / NF (United States Pharmacopeia) testing
- EP (European Pharmacopeia) testing
- JP (Japanese Pharmacopeia) testing
ARL provides full laboratory services for pharmaceutical and biotechnology companies. Laboratory services include testing for New Drug Application (NDA), Abbreviated New Drug Application (ANDA), medical devices (510K) and over-the-counter products.
- Stability Studies
- Compatibility Studies
- Raw Material Testing
- Dissolution Testing
- Microbial Identification
- Bioequivalence Studies
- Pre-clinical and Clinical Analytical Testing
ARL Bio Pharma provides comprehensive services to solve challenging drug investigations. These services are unique and specialized in pharmaceutical, toxicological, regulatory support, and research and development.
- Chemical Analysis
- Biological Analysis
- Drug Diversion Testing
- Complaint Sample Testing
- Product Contamination
- Litigation Support
- Patent Infringement
- Literature Research and Review
LATEST AROUND THE INDUSTRY
Open vs. Closed Membrane Filtration...
According to USP <71> Sterility Tests, membrane filtration is the sterility test method of choice for filterable pharmaceutical products. Membrane filtration refers to either an open membrane filtration (OMF) or closed membrane filtration system. Not all sterility test systems are the same. It is important pharmacists know the differences between the two systems to reduce the risk of false positive results, costly investigations, and batch loss.
USP <71> Sterility Testing
USP <71> Sterility Tests is a general chapter enforceable by regulatory agencies and is applied to substances, preparations, and articles required to be sterile. This chapter demonstrates process control and is a general indicator of the microbiological quality of a product. It's important to note that the <71> "pharmacopeial procedures are not by themselves designed to ensure that a product or batch is sterile or has been sterilized. This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures." For ARL to list USP <71> as the test method, pharmacists must certify and submit the correct number of articles in accordance with Table 3 in the chapter.
A sterility test is performed under aseptic conditions. Precautions are taken to avoid contamination, so the testing environment does not impact any microorganisms that are to be revealed during the test. ARL Bio Pharma regularly monitors working test conditions by appropriate environmental sampling of the work area and carrying out suitable controls.
ARL Sterility Test Process:
- ARL performs growth promotion testing and assesses other quality parameters to confirm that each lot of ARL's media can support growth of the six microorganisms stated in USP <71> Sterility Tests.
- Prior to conducting a USP <71> sterility test, our laboratory performs method suitability for each specific product formulation to ensure that an appropriate method is chosen for testing.
- During performance of a sterility test, ARL uses either a closed membrane filtration method (the preferred method, when possible) or a direct inoculation method for unfilterable sample types. To ensure that a sterility test is USP <71> compliant, ARL tests the correct sample volume according to Table 2 in the chapter. The test containers are then incubated at the appropriate temperatures for at least 14 days.
- At the end of the incubation period, each test is examined for signs of microbial growth, which generally present as turbidity or cloudiness of the media.
At the conclusion of the test, if there is no evidence of growth, the drug product complies with the USP <71> test for sterility. A "Sterile" result indicates that no contaminating microorganism is found in the sample examined under the conditions of the test.
If the test reveals signs of contamination, the drug product is considered "Not Sterile" and an OOS investigation will be initiated.
For more information on Sterility Testing, visit the articles and webinar below: