ABSTRACT
INTRODUCTION Sterile products may be in liquid or powder form (among others) as drug products and may be presented in formats including ampoules, vials, prefilled syringes, presterilized bottles, and blow-fill-seal containers. Product form and presentation influence processing conditions, equipment selection, and therefore, facility design. The sterile envelope refers to all the steps carried out during and following the final sterile filtration step through process completion, which occurs after filled product containers are sealed and a risk of environmental contamination to the product is eliminated. These steps include:
l Adjuvant, buffer and media formulation l Addition of excipients l Adjustment of concentration to achieve target potency l Sterile filtration l Component preparation l Filling, stoppering/plugging, and sealing of product in final dosage containers
The design of the facility must meet all applicable regulatory guidelines, and meet GMP and safety guidelines. Current Good Manufacturing Practice (GMP) requires that areas of operation used for aseptic processing must prevent contamination from particles and microbes that may be present in the air, on product contact surfaces, or shed from personnel (1-5).
