ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Aseptic Transfer (in Isolators)

The key issue in all contained aseptic environments. Aseptic transfer is essential for change parts, components, and even product to enter and exit an isolator system without sterility challenges. There are an increasing number of ways to make an aseptic transfer. The following is a brief list of some of the key techniques:

1. Alpha Beta Systems Double Door Systems: also called RTPs (Rapid Transfer Ports) and HCT (High Containment Transfer). When mated, the two ports act as one door, protecting the internal and external environments.

2. Alpha Beta Dry Heat Sterilized: similar to Alpha Beta port with the additional safeguard of a heat sterilized seal.

3. UV and Pulsed Light: light sterilization/sanitization. Sterilizing the system by making use of a wide spectrum of light within the transfer chamber.

4. One Shot Systems: basically, two halves coming together. Similar to an Alpha Beta port but simpler, cheaper, and capable of only a single connection.

5. Heat Welded Bag Systems: passed in or passed out using a continuous polyethylene liner which is heat sealed and cut to maintain the integrity of the internal and external environments.

6. Steam Sterilized: the liquid component or powder path is clean steam sterilized after connection and prior to transfer.

7. Autoclave/Depyrogenation/Dryheat: pass through for batch. Use of conventional autoclave to sterilize a canister provided with an Alpha Beta port and filters to allow the passage of steam and safe aspiration on cooling. Depyrogenation/Dryheat uses dry heat to sterilize and at sufficient temperature depyrogenate components, typically glassware, in a batch oven

8. Depyrogenation Tunnel: standard volume glassware entry. Depyrogenation/Dry heat uses dry heat to sterilize and at sufficient temperature to depyrogenate components, typically glassware, in a tunnel allowing continuous input.

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