California pharmacies

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.

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.

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 measures the level of hazardous drug surface residue to verify workplace safety.

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

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

This test measures the concentration of the active ingredient at a specific point in time.

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

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.