Microbiology Testing

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Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.

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Fungal

This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products.

Microbial Identification

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

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Antimicrobial Effectiveness Testing USP <51>

Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>

This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations.  This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration. 

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Growth Promotion

Growth Promotion demonstrates that media used in environmental monitoring programs, media fills, or personnel qualification are capable of supporting microorganism growth.

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Microbial Disinfectant Cleaning Challenge Studies

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.

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Container Closure Testing

The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include: 

  1. Entry of microorganisms
  2. Escape of the product dosage form or entry of liquids or solids
  3. Escape of nitrogen gas or entry of oxygen, water vapor, or air gase

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ISO 11737-1 - Bioburden / Microbial Enumeration

ISO 11737-1 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

This is a literature method that provides general guidance on bioburden testing as a demonstration of continued product quality.

Testing includes:

  • SOP derived from ISO method and testing protocol
  • Method Suitability
  • Bioburden Test

ISO 11737-2- Sterility

ISO 11737-2 specifies the general criteria for sterility tests on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating, or maintaining a sterilization process.

Mycoplasma Testing

ARL Bio Pharma offers a formulation specific, validated nucleic acid amplification PCR method to screen test samples for mycoplasma. In all cases, careful aseptic technique, appropriate laboratory conditions, and a highly trained staff are able to properly interpret the results are required.

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All services provided will adhere to ARL Bio Pharma’s terms and conditions