Antimicrobial Test Laboratories (ATL) Now Provides Customized Validation of Disinfection for Pharmaceutical Manufacturers
Antimicrobial Test Laboratories (ATL) – an FDA GLP compliant microbiology lab founded in 2006 by microbiologist Dr. Benjamin Tanner – now offers robust services for validating disinfection in pharmaceutical manufacturing environments.
Round Rock, TX (PRWEB) November 30, 2013
Antimicrobial Test Laboratories (ATL) – an FDA GLP compliant microbiology lab founded in 2006 by microbiologist Dr. Benjamin Tanner – now offers robust services for validating disinfection in pharmaceutical manufacturing environments. Because pharmaceutical facilities vary in products, surfaces, and types of microbial contaminants, FDA requires pharmaceutical makers to validate disinfection procedures on a facility-by-facility basis. ATL assists companies in designing and executing disinfection validation studies that are appropriate to their environments.
2014 disinfection validation studies will be customized and sized for client needs and budgets to include:
- GLP test conditions: a robust and highly traceable form of conducting studies.
- Standard methods, such as a modified AOAC Germicidal Spray Products Test Method or modified ASTM E 1153 Test Method.
- The products that are used in-house are the products that are tested.
- A broad range of microorganisms can be used in testing, including “standard” microorganisms like S. aureus, E. coli, P. aeruginosa, and A. niger.
- Additional microorganisms isolated from production environments are tested. Typically three isolates are chosen. Common problematic contaminants include Micrococcus species, Bacillus species, and Pseudomonas species.
- Validations are conducted in triple replicate. Increased replicates ensures more robust and reliable data.
- Studies are designed and run to perfectly meet all regulatory expectations. Experienced ATL staff is familiar with regulatory requirements. Additionally, reports generated are regulatory agency “friendly.”