Aseptic Manufacturing Facility

Pii’s aseptic facility was built to the FDA’s most current design guidance, utilizing the most up-to-date engineering controls and practices to ensure sterility.  The facility features open isolation systems which separate the external clean room environment from the aseptic processing line and minimizes exposure to personnel. Positive pressure rigid wall construction, incorporating stainless steel and glass materials, isolates the product filling from the external class 100 clean room, therefore greatly reducing the chance for microbial contamination during processing.

 

Looking Ahead

Pii is expanding its sterile manufacturing area with an additional 24,000 sq. ft. of manufacturing space. Targeted for completion in late 2012, the new facilities will enable Pii to further meet clients’ growing demand for sterile fill / finish and lyophilized manufacturing. Read more.

 

Sterile Contract Development and Manufacturing Services include:

  • Formulation development and process validation
  • Analytical methods development and validation
  • Analytical testing, including microbial
  • Stability Studies
  • Process optimizaiton
  • Scale up to commerical production
  • Small scale commercial manufacturing
  • Potent and cytotoxic products
  • Controlled substances
  • Vials (2mL to 100mL)
  • Syringes (0.5mL to 20mL)
  • Lyophilized products
  • Ethanol-containing solutions
  • Sterile liquids, suspensions and emulsions

 

Pii can meet your needs at any stage of your sterile product's lifecycle, with fully integrated development services and commerical manunufacturing in one location. Contact us today to learn more.

 

Click here, for a list of Pii's aseptic manufacturing equipment capabilities.