Pfizer, Sterile Manufacturing Expansion

DPS was engaged to carry out a Site Master Plan and Concept Study for a new sterile manufacturing expansion for a vial filling and lyophilisation facility.

Location: Spain
Sector: Biopharmaceutical

About This Project

The master plan assessed the opportunities on the existing site for cost effective logical development, including all aspects of a manufacturing facility; supply chain, materials handling, warehousing, dispensing, QC laboratories, utilities, administration and traffic management.

The concept design involved 2 separate sub-projects; 

  • Multi-product Aseptic Area - standalone independent 3 floor facility with dispensing, formulation, equipment prep., filling and lyophilisation with future expansion opportunities. 
  • CA2E – Current Aseptic Area Expansion – reduced cost option, leveraging existing aseptic suite facilities for shared services, equipment wash and preparation and formulation.

The concept study addressed the most space and cost effective design for a new isolated filling line with lyophilisers and assessed a number of manufacturing strategies.

Key Project Attributes

The concept design involved a significant capacity analysis exercise utilizing Schedule Pro, where numerous manufacturing strategies were assessed to enable the most cost effective, operationally efficient option to be developed.  A number of technology assessments were undertaken and white papers generated which were reviewed and risk assessed in order to take considered decisions;

  • Formulation Strategy
  • Single Use Fluid Path Design
  • Lyo Refrigeration
  • Lyo Load and Unload 
  • Isolator vs RABs

The main long lead equipment URS’s were developed and budget quotations solicited from a range of vendors.

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