|
E n g l i s c h |
| ACE | air change effectiveness |
| AHU | air-handling-unit |
| AMC | airborne molecular contamination |
| ANSI | American National Standard Institute |
| CAPA | Corrective and preventive actions |
| CAS | Chemical Abstracts Service | |
| CFU | Colony forming unit |
| cGMP | current Good Manufacturing Practice |
| CIM | Computer Integrated Manufacturing |
| CIP | Cleaning in place |
| CRE | contaminent removal effectiveness |
| DEHS | liquid organic ester (diethylhexyl sebacate) |
| DQ | Design Qualification |
| ePM | particulate matter efficiency |
| ESD | electrostatic discharge |
| FAT | Factory Acceptance Test |
| FCC | Food Chemical Codex |
| FDA | Food and Drug Administration |
| FMEA | Failure Mode and Effect Analysis |
| GDP | Good Distribution Practice |
| GEP | Good Engineering Practice |
| GMP | Good Manufacturing Practice |
| HACCP | Hazard Analysis Critical Control Point |
| HEPA | High Efficiency Particulate Air |
| HPW | Highly purified water | |
| HVAC | Heating Ventilation Air Conditioning |
| IDA | indoor air |
| IEST | Institute of environmental scienses and technology |
| IQ | Installation Qualification |
| LF | Laminar Flow |
| MCP | microbe-carrying particle |
| MPPS | most penetrating particle size |
| Non-UDAF | non-unidirectional airflow |
| ODA | outdoor air |
| OOS | out of specification |
| OOT | out of trend |
| OQ | Operational Qualification |
| PM | particulate matter |
| PQ | Performance Qualification |
| SAT | Site Acceptance Test |
| SUP | supply air |
| UDAF | unidirectional airflow |
| UDF | unidirectional flow |
| ULPA | Ultra Low Penetrating Air |
| URS | User requirements specifications |
| VMP | Validation Master Plan |
| WFI | Water for injection |