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WELCOME TO ARL BIO PHARMA

ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry. Our laboratory works with pharmaceutical companies, compounding and hospital pharmacies, drug manufacturers, and raw material suppliers bringing excellence to pharmaceutical sciences.

Industries

Pharmacy

Pharmacy

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.
Services Offered:

 

  • Potency Determination
  • BUD and Stability Studies
  • Sterility
  • Endotoxin
  • Fungal
  • Microbial Identification
  • Microbial Enumeration Tests
  • Tests for Specified Organisms
  • Antimicrobial Effectiveness Testing
  • Particulate Matter by Light Obscuration
  • Particulate Matter by Microscopy
Raw Material

Raw Material

ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
Services Offered:

 

  • 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
  • pH
  • Viscosity
  • USP / NF (United States Pharmacopeia) testing
  • EP (European Pharmacopeia) testing
  • JP (Japanese Pharmacopeia) testing
Pharmaceuticals

Pharmaceuticals

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.
Services Offered:

 

  • Stability Studies
  • Compatibility Studies
  • Raw Material Testing
  • Dissolution Testing
  • Microbial Identification
  • Bioequivalence Studies
  • Pre-clinical and Clinical Analytical Testing
Forensics

Forensics

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.
Services Offered:

 

  • Chemical Analysis
  • Biological Analysis
  • Drug Diversion Testing
  • Complaint Sample Testing
  • Product Contamination
  • Litigation Support
  • Patent Infringement
  • Literature Research and Review

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Microbial Tests for Non-Sterile Products

3D Rendering of Microbial Bacteria

USP <795> states that pharmacists performing non-sterile compounding must ensure that the finished preparation has its accepted potency, purity, quality, and characteristics.  This article discusses the tests described in USP <61> and USP <62> that are used to determine if non-sterile products meet quality requirements.  These tests can also be used by sterile compounders for qualifying raw materials and performing in-process quality control testing. 

Testing Conditions

The general considerations for testing non-sterile products are much like USP <71> Sterility testing.  Growth promotion is required to demonstrate that every lot of media will grow the microorganisms required for each test.  Method suitability is also performed prior to product testing to establish the ability of the test to detect microorganisms in the presence of the specific formulation to be tested.  All testing must be completed under aseptic conditions to avoid extrinsic microbial contamination of the product tested and must include proper positive and negative controls.  

USP<61> Microbial Enumeration Tests

USP <61> is often called “Bioburden” or “Microbial Limits” because the test determines how many microorganisms are present in the sample.  To perform the test, the sample is plated onto two types of growth media (Soybean-Casein Digest Agar and Sabouraud Dextrose Agar).  The plates are incubated at a defined temperature and duration.  At the conclusion of the test, the number of colonies present on the plates are counted and the results calculated.   The results can then be compared to the acceptance criteria.  USP <1111> can be referenced for acceptable amounts of microorganisms present based on whether the sample is a raw material or finished drug product.  If the sample is a finished drug product, the acceptance criteria depends on the route of administration. 

USP<62> Tests for Specified Organisms

USP <62> provides instructions on how to perform tests that demonstrate particular microorganisms are not present in non-sterile substances and products.  These tests are performed similarly to USP <61> tests, but with microorganism specific growth media.  At the conclusion of incubation, a result of “Pass” or “Fail” is generated.  A passing result indicates the absence of the tested specified microorganism.  USP monographs and <1111> define which organisms to test based on the route of administration of the raw material or finished drug product.  For example, USP <1111> recommends that cutaneous (topical) products be tested for the absence of both Pseudomonas aeruginosa and Staphylococcus aureus,  versus an oral preparation where the recommendation is to test for the presence of Escherichia coli.

Please contact ARL (800) 393-1595 or info@arlok.com with questions.

Andrew Taylor, Microbiology Supervisor

Reference Documents:
United States Pharmacopeia <61>

United States Pharmacopeia <62>

United States Pharmacopeia <1111>