Pharmaceutical Testing Services
Accuratus Labs understands the challenges faced by pharmaceutical manufacturers to ensure they are operating under microbial contamination control and producing products having antimicrobial stability. We know that no two facilities are the same and whether you operate in a sterile or simply an aseptic, non-sterile manufacturing environment, the certainly that the cleanroom environment is contamination free is paramount. Accuratus Labs helps our partners be confident that their controlled environments are adequate for the manufacture of pharmaceuticals. This is not only an obligation to your customers in guaranteeing safe product, but a requirement by regulatory agencies certifying current Good Manufacturing Practices (cGMP) are followed.
The US Food and Drug Administration’s (FDA) guidance document –Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice carefully outlines the programs pharmaceutical manufacturers must comply with. At Accuratus Labs, we are able to help manufactures adhere to these programs.
Cleaning and disinfection is critical in maintaining a microbial controlled aseptic environment. As such, the US FDA GMP’s require aseptic manufactures of pharmaceuticals to qualify the effectiveness of the disinfectants and procedures used for their application. This requirement is further substantiated in FDA inspection reports and Form 483 observations. Accuartus Labs has years of experience assisting clients with the development and execution of robust disinfection qualifications that stand up to FDA scrutiny and is based on United States Pharmacopeia (USP) <1072> guidance.
To improve the antimicrobial stability of multi-dose and semi-solid pharmaceutical products (ointments and creams), preservatives are often incorporated during manufacturing. Accuratus Labs provides developers and manufactures of pharmaceuticals with antimicrobial preservative efficacy testing to assure appropriate formulation and product safety in the hands of the consumer. We perform testing to be measured to the criteria outlined in USP <51>.
When results need to be accurate beyond doubt and helpful beyond measure, partner with Accuratus Lab Services.
Contact Us with any questions. We are happy to take you through the disinfectant testing process.