Who We Are
Since 1970 the Prince name has been synonymous with pharmaceutical and medical testing and research excellence. The award winning team of Gibraltar Laboratories is proud to expand its scope to become the premier provider of pharmaceutical steam and dry heat sterilization services and ready to use custom vials. The Prince Sterilization Services [PSS] management team is made up of industry wide subject matter experts including Herbert, Daniel and Derek Prince.
PSS is ready to qualify a sterilization cycle that fits your needs. A validated steam or dry heat sterilization cycle will typically use the overkill or product specific (bioburden) based approach, ultimately achieving a probability of non-sterile unit (PNSU) or sterility assurance level (SAL) of ≤10-6. Routine release of products validated using this type of cycle are typically based on parametric release, inclusion of a BI, or confirmatory USP <71> testing on a portion of the load.
We begin our work with the careful selection of development cycles to optimize parameters to be validated as per FDA requirements.
A validated depyrogenation cycle typically involves a ≥ three log reduction of endotoxin. With respect to depyrogenation by heat these types of cycles typically operate at temperatures from 170 to 400°C and serve to destroy bacterial endotoxins. When dry heat depyrogenation is not an option but a pyrogen-free claim is still required, Prince is equipped to offer depyrogenation claims by washing with USP/EP WFI. This process is also capable of producing a ≥ three log reduction of endotoxin and allows the product to be certified pyrogen-free while maintaining product integrity for heat labile materials.
At Prince, we also understand that certain customers do not have the resources, time or space to wash, develop, validate, and certify manufacturing materials such as vials, seals and stoppers in-house. For this reason we process vials and stoppers submitted by our sponsors and offer a variety of custom SKUs of ready to use kits (SteriKit®) containing sterile (USP <71>), pyrogen (USP <85>) and particulate (USP <788>) free vials, seals, and stoppers. All of these components have been processed according to internal validations and a CoA is available after purchase. We consider this the Prince Advantage® as it allows our customers to focus on manufacturing while saving them time, space, and money.
At Prince, we strive for continuous improvement which is why we invested and continue to invest heavily in our processes and personnel by providing continuous improvement training seminars, including lean manufacturing and 5S visual management. All operations are performed as per cGMP guidance. The entire process from sample pass through, sample preparation, sterilization, and final packaging are performed in ISO certified clean rooms and FDA registered laboratory space.
We invite you to learn more about our services and products by browsing our webpage or contacting an expert technical sterilization services rep.