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.
Disinfectants used routinely in the manufacturing industry must be verified to confirm effectiveness for facility use. Disinfectant efficacy testing consists of two test types:
- Suspension testing: to determine if the disinfectant has sufficient properties to kill the specified organism at the contact time and temperature specified in the testing standards (BS EN: 1276 (Bactericidal Activity), BS EN: 1650 (Fungicidal Activity) and BS EN: 13704 (Sporicidal Activity)) .
- Surface testing: to determine if the disinfectant has sufficient properties to kill the specified organism on a particular surface where the disinfectant may be used in the manufacturing facility i.e. stainless steel in a clean room for the specified contact time and temperature as per the standard BS EN: 13697 (Surface Testing).
Testing is also performed in the presence (dirty conditions) or absence (clean conditions) of interfering substance (skim milk powder or Bovine Albumin) to help mimic the use of the disinfectant in the manufacturing facility.
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 Irelands leading GLP certified (INAB), 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)
- Disinfectant efficacy testing (D.E.T)
- 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