Microbiology testing

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

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.

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.

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

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.

These tests quantitate the total population of aerobic bacteria, yeast, and molds in raw materials, in-process samples, and finished products.

These tests verify the absence of objectionable microorganisms in drug products and raw materials.

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.

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

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.

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

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.

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.