Foothill Ranch, CA
ACTA runs USP <61> microbial enumeration and USP <62> tests for specified microorganisms under cGMP, with acceptance criteria applied per USP <1111> or client specifications. Send us a non-sterile product, raw material, or in-process sample and a microbiologist scopes the work.
ACTA performs USP <61> Microbial Enumeration Tests, the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC), together with USP <62> Tests for Specified Microorganisms. This work applies to non-sterile drug products, raw materials, OTC products, and in-process samples. Acceptance criteria are applied per USP <1111> or client specifications.
ACTA also screens for Burkholderia cepacia complex per USP <60> on aqueous non-sterile products, and establishes method suitability by recovery validation before routine testing. Bioburden testing per USP <1119> and <1119.1> gives you the pre-sterilization counts your sterilization validation depends on. The microbiology laboratory runs this work in-house, and you receive a cGMP Certificate of Analysis (COA).
Microbial limits testing answers two questions about a non-sterile product. How many organisms are present, and are any of them objectionable.
USP <61> is the quantitative side. The sample is plated on soybean-casein digest agar for the total aerobic microbial count and on Sabouraud dextrose agar for the total combined yeasts and molds count, then incubated and counted. Results are reported in colony forming units per gram or per milliliter.
USP <62> is the qualitative side. The sample is enriched and screened for specified organisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, bile-tolerant gram-negative bacteria, Candida albicans, and Clostridia, with the organism set chosen by the route of administration. Before any routine testing, method suitability is established so the product does not inhibit recovery. Counts and organism results are then compared against the acceptance criteria in USP <61> or <62>.
The product is homogenized, neutralized, and plated on TSA and SDA. Colonies are counted in CFU per gram, and counts and specified-organism results are checked against USP 1111 limits. Hover any stage to see what it does.
The large labs route a single microbial limits project into a queue that can take weeks to start. ACTA takes the one product, scopes it with a microbiologist, and follows up. Many of our largest accounts started as one small test.
Inside the lab
Every plate is prepared, incubated, read, and counted by a microbiologist on our bench. Microbial Limits under USP <61>, Specified Organisms under USP <62>, plus bioburden and enumeration.
When a plate reads out of specification, a microbiologist follows up.
Microbial limits, bioburden, endotoxin, and AET under cGMP.
View →
USP <85> LAL endotoxin testing for water, parenterals, and devices.
View →
TOC, conductivity, and microbial enumeration for water systems.
View →
Method development and validation to USP and ICH.
View →
cGMP storage with scheduled, monitored pull testing.
View →
Compendial and custom methods across instruments.
View →
