|
Term
|
Description
|
| Ultimate Vacuum |
The vacuum (lowest pressure) that a particular vacuum pump can achieve in a clean, dry leak-free system. |
| Vacuum |
Strictly speaking, a space in which the total pressure is less than atmospheric |
| Vacuum Break |
A special VBS vacuum solenoid designed to isolate the vacuum pump from the condenser and product chamber during power failure |
| Vacuum Break Valve |
A valve for the admission of gas for breaking vacuum |
| Vacuum Control |
(Gas Bleed) Control of pressure in the freeze drying chamber to provide the most favorable balance between heat and vapor transfer to and within the product to achieve a minimum primary drying time consistent with the maintenance of product quality. |
| Vacuum Pump |
A mechanical means of reducing the pressure in a vessel below atmospheric to facilitate sublimation. There are various types of vacuum pumps including oil sealed rotary vane, dry pumps, rotary piston and mechanical booster pumps |
| Vacuum Valve |
Vacuum valves close without leaking and may be of ball or disk (butterfly) or other design. |
| Validation |
Establishing documented evidence that a system does what it purports to do. |
| Validation Change Control |
A formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect validated status and cause corrective action to be taken that will ensure that the system retains its validated state of control |
| Validation Guide |
A validation guide and workbook consisting of a series of FDA required lyophilizer performance tests and audit reports. |
| Validation Protocol |
A prospective experimental plan that, when executed , is intended to produce documented evidence that the system has been validated |
| Validation Task Report |
A scientific report of the results derived from executing a validation protocol |
| Validation Task Report Conclusions |
A brief summary of conclusions from a specific task report, usually indicating validation success and designating proven acceptable ranges that have resulted. The conclusions are formally approved |
| Vapor Baffle |
An object placed in the condenser to direct vapor flow and to promote an even distribution of condensate |
| Vapor Valve |
(Isolation Valve) The vacuum valve between the chamber and the external condenser. When this valve is closed the chamber is isolated from the external condenser |
| VHP |
Vaporized Hydrogen Peroxide. May be utilized as a chemical sterility in freeze dryers or as a vehicle for other chemical sterility |
| Vial |
(Serum Bottle, Serum Vial) In freeze drying, small glass bottles with a flat bottom, short neck and flat flange designed for in-situ stoppering. Vials may be molded or tube drawn. |
| Virtual Leak |
In the vacuum system a virtual lead is the passage of gas into the chamber from a source located within the chamber itself. |
| Volatile |
Having a strong tendency to evaporate at room temperature. Having a high vapor pressure |
| Warming |
Raising the temperature in any part of the temperature scale |
| WFI |
Water for Injection. This water is required for preparing parenteral solutions and manufacturing drug products |