Microbiology testing

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.

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.

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.

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

This test incubates and observes the media and plate samples according to client instructions and provides a certificate of analysis with CFU count.

A disinfectant efficacy study evaluates the effectiveness of cleaning agents in eliminating microorganisms that can be found in a client’s pharmaceutical compounding area. This study ensures that the disinfectants used meet the manufacturers defined dwell times and are effective in removing microbial growth commonly found in a clients’ facility and in environmental monitoring recoveries. By demonstrating the performance of disinfectants, these studies help prevent cross-contamination, safeguard product integrity, and ensure compliance with industry regulations.

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

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

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.

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.

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.

Microbiological Examination of Nonsterile Product. 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.

Microbiological Examination of Nonsterile Product. These tests verify the absence of objectionable microorganisms in drug products and raw materials.