Glossary

A spore produced within the saclike (ascus) cell of the sexual state of a fungus.

American Society for Clinical Pathology

American Society for Clinical Pharmacology and Therapeutics

Autologous Skin Cell Transplant

Atherosclerotic Cardiovascular Disease

Atrial Septal Defect

Assistant Secretary of Defense for Homeland Defense

Association of South-East Asian Nations (RHI)

A condition in which living pathogenic (causing or capable of causing disease) organisms are absent.

Processing conditions designed to achieve a sterile product.

Asepsis or sterile. The state of being free of contaminating organisms (bacteria, fungi, algae and all micro-organisms except viruses) but not necessarily free of internal symbionts.

Free of pathogenic (causing or capable of causing disease) microorganisms.

Not sterile, but contaminants controlled within established acceptable limits.

Not sterile, but contaminants controlled within established acceptable limits.

(PDA TR 22) Free from disease-producing microorganisms.

Not sterile, but contaminants controlled within established acceptable limits.

A type of closed isolator that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and is able to be reproducibly decontaminated. When closed it uses only decontaminated interfaces or Rapid Transfer Ports (RTPs) for material transfer. When open it allows the egress of materials through a defined opening that has been designed and validated to preclude the entry of contamination.

Operating in a manner that prevents contamination of the process.

(PDA TR 22) Handling sterile materials in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to control microbial and particulate contamination to acceptable levels.

Area in which sterile product is formulated, filled into containers, and sealed.

The transfer of material from a vessel or process to another vessel or process without introduction of contamination from outside the process.

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 oven8.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.

Any type of reproduction not involving meiosis or the union of gametes.

American Society for Gastrointestinal Endoscopy

American Society of Hematology