Many customers rely on RSSL for a range of tests focused on ensuring the microbiological safety of pharmaceutical products.
Routine services include microbial limits testing for specific pathogens, bacteria, yeast and moulds (EP, BP, USP, CP and JP), quantitative endotoxin analysis, preservative efficacy testing, environmental monitoring, water testing and method development and validation.
Regulatory pressures have pushed cleaning validation higher up the agenda of pharmaceutical manufacturing.
RSSL offers consultancy and training in this discipline alongside the services of its testing laboratories (chemistry and microbiology). The predominant growth area for RSSL in recent years has been in cleaning validation.
Darlington Nwodo, RSSL's Microbiology Manager, said:
“As a GMP requirement, cleaning validation must be undertaken with the utmost care. Our additional lab space and new Biological Safety Cabinets will enable us to support more customers in meeting their obligations to provide safe pharmaceutical products.”
A key role for the microbiology laboratory is to test the efficacy of chemical disinfectants used in pharmaceutical and healthcare environments to ensure they achieve the required standards.
The laboratory follows British and European Standards, applying a variety of tests which include suspension and surface testing. The surface test procedure involves inoculating relevant surfaces with a level of various organisms.
The disinfectants are applied to the artificially contaminated surfaces after a drying phase. The level of log reduction achieved from this process is used to determine the efficacy of the disinfectant and if it is fit for purpose.
RSSL is established in the provision of analytical, investigational, consultancy and training services to clients in the pharmaceutical, biopharmaceutical and healthcare sectors.
The company's chemical, physical, biochemical, biological and microbiological services are wide ranging, and provide support through the full drug product lifecycle. RSSL is routinely inspected by the MHRA, FDA and UKAS.
