Project Experience

Our experienced Process Technology personnel are able to assist you to identify critical process parameters and manufacturing limitations. We can lead and manage your drug delivery project for new product launches. We can establish engineering limits through process efficiency studies, design experiments for pre-validation engineering investigations, write the process validation protocols and oversee the work.

Process
► Weighing, screening, milling, blending, wet and dry granulation, fluid bed, flash and spray dryers, tableting, film coating, filling.
► Non-sterile liquids, pastes and suspensions: compounding suites, mixing vessels, homogenizers, milling, micronization, pumping, emulsifying, filling, packaging.
► Sterile liquids: compounding suites, media kitchens, CIP and SIP, filtration, fermentation, autoclaves, fill suites, sterilization tunnels and ovens, filling, freeze drying, inspection stations, terminal sterilization, packaging.
► Bulk pharmaceutical ingredients and excipients: centrifugation, distillation, hydrolysis, precipitation, crystallization, dryers, filter presses, ultra-filtration, dialysis, CIP and SIP, packaging.
► Process and product safety reviews.

Facilities
► Bio level 1, 2, 3 laboratories; analytical laboratories;
► Microbiological; Pharmaceutical manufacturing;
► Research and development pilot plants;
► Office and support areas; utility plants;
► ISO 5 (Class 100) to ISO 8 (Class 100,000) clean rooms.

Utilities
► Water for injection (WFI), reverse osmosis (RO) water
► Process piping, clean in place (CIP), steam in place (SIP), clean steam
► Pharmaceutical grade oil free compressed air, nitrogen
► Heat transfer water, HVAC, refrigeration
► All other associated plant utilities.

Controls / Instrumentation
► All aspects of PLC, DCS, MMI, MES systems.
► Adept at validation requirements & execution, and most types of programming.