Sterile Vials

Sterile Vials

By incorporating sterility vials, companies can streamline their focus on core business activities, expediting the development and introduction of products to the market. The utilization of Type I molded glass enhances mechanical resilience, thereby minimizing the potential for particle contamination resulting from breakage during crucial fill/finish and Lyophilization stages. Qorpak provides these high-quality sterile vials in convenient case pack quantities, enabling companies to efficiently outsource non-core functions, optimizing overall efficiency and productivity in their operations.

Validation Process

• 100% inspected in clean room environment

• Vials are washed with water for injection & dried in an ISO8 environment

• Vials are depyrogenated in a tunnel according to European & US Pharmaccopeias

• Vials are placed in trays or in nest & tubs packaging in ISO5 area with ISO7 surrounding

• Sealed with a Tyvek® lid in ISO5 environment, packed in steribags and placed into a box allowing for sterilization in ISO8 surrounding

• Sterilized by EtO using validated process meeting ISO11135 requirements. This final step grants the highest cleanliness of all the packaging components and reduces the risk of microbiological contamination of the aseptic area.