Services

PPS maintains a GMP compliant pharmaceutical Quality Management System covering all service operations offered from the facilities in Reno, NV. The PPS Quality Management System follows the United States CFR, Title 21, Parts 210/211, EU GMP, ICH Guidance documents Q7/Q9/Q10, and ISO 9001:2008, as applicable to the services offered.

PPS handles both non-GMP and GMP materials across the entire supply chain for small molecules, biologics, medical devices, veterinary products, and nutritional and consumer goods. In addition, PPS provides controlled temperature storage for non-clinical and clinical retains and other pharmaceutical development materials requiring careful stewardship.

controlled temperature Storage

20C, 5C, -20C, -75C, and -196C (vapor phase liquid nitrogen)
All conditions qualified, mapped and continuously monitored
Emergency backup-power diesel generators, all conditions
Pallet capacity to 500 spaces, including oversized pallets
Upright, front-loading controlled temperature chambers
Cryogenic storage segregated by cell line
Starting materials, intermediates, excipients, bulk API and DP
Ecoli and mammalian derived cell lines
Non-clinical and clinical retains, clinical supplies, R&D libraries

Material Dispensing

ISO-8 qualified clean room with HEPA filtered supply air
Continuous temperature and humidity monitoring
Aliquoting non-GMP and GMP powders and liquids, mg to Kg
Single-use disposable product contact supplies
Pharmaceutical grade primary containers and custom sourcing
Calibrated and maintained balances and test weights
SOP-driven procedures, all activities documented
Extensive operator training, supervision, and Quality review

clinical Labeling

Open and blinded labeling of investigational products
In-house label design, proofing and printing
Labeling bright stock and vials, clinically durable poly labels
Labeling at ambient and controlled time-out-of-environment
Human sample collection kit design, labeling, and assembly
Just-in-time labeling and emergency turn-around
Label production and manufacturing documented and reviewed

global Distribution

Global distribution and logistics support
Ambient, controlled ambient, 5C, -20C, -75C and -196C
Standard and validated shipping containers, box to pallet
USB-ready temperature recorders
Prepared shippers for clinical returns and recalls
FedEx, DHL, UPS, World Courier, Marken, Biocair, Yourway