Microbiology Testing

Pharmaceuticals, biopharmaceuticals, biologics and medical devices need to be produced in accordance to the strictest cGMP requirements and must have release testing packages carefully designed to demonstrate compliance. Microbiology testing provides knowledge and understanding to the presence of any microorganisms and toxins in raw materials, intermediates, finished products, etc.

Our microbiology testing service is performed to internationally recognised methods such as European, United States and British Pharmacopoeias and we have the capability to develop bespoke microbiological testing methods to meet client specific requirements.

Our significant experience in cGMP microbiology testing of raw materials, finished products and water systems includes oral products (liquids, capsules, tablets etc), topical products (creams and ointments), injectables, transdermal, ophthalmic, purified, potable and in-process water systems.

Pharmaceuticals, biopharmaceuticals, biologics and medical devices need to be produced in accordance to the strict cGMP requirements and must have release testing packages carefully designed to demonstrate compliance. Our excellent microbiology testing track record ensures our continued position as Ireland’s leading cGMP certified (HPRA) and FDA registered contract laboratory.

Our microbiology testing versatility and capacity to integrate exceptional technical expertise and quality management with a range of related services, enables us to offer a complete range of development services to our clients.

Microbiology testing services:

• Microbial limits testing (MLT) and validation (MLTV)
• Preservative efficacy testing
• Bioburden validation and analysis
• Endotoxin testing gel clot method
• Growth promotion testing of cultured media
• Incubation of environmental monitoring samples
• Specialist microbiology services for medical device industry
• Identifications of bacterial cultures using phenotypic method
• Sterility testing on biological indicator strips ampoules
• Medical devices