INTERNATIONAL STANDARD | ISO 22519 First edition 2019-06 | ||
Purified water and water for injection pretreatment and production systems Systèmes de prétraitement et de production d'eau purifiée et d'eau d'injection | |||
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| ACF | activated carbon filter |
| AS | antiscalant |
| BW | butt welding |
| CD | chlorine dioxide |
| CFU | colony forming units |
| CIP | cleaning in place |
| CIT | conductivity indicator and transmitter |
| CLIT | chlorine indicator and transmitter |
| DPRO | double pass RO |
| EP | European Pharmacopeia |
| EPDM | ethylene propylene diene monomer |
| ESC | electric scale control |
| FAT | factory acceptance test |
| FIT | flow indicator and transmitter |
| FRP/PE | fibre reinforced plastic (on) polyethylene |
| FS/DF | filter screen/disk filter |
| GAC | granular activated carbon |
| GMP | good manufacturing practice |
| HOD | hydro optical dechlorination |
| HP | high pressure |
| HSDS | Human Services Data Specification |
| HWS | hot water sanitization |
| ID | inside diameter |
| IQ | Installation Qualification |
| ISPE | International Society for Pharmaceutical Engineering |
| JP | Japanese Pharmacopeia |
| L/D | ratio between piping/tubing length/diameter |
| LT | level transmitter |
| MF | microfiltration |
| MMF | multimedia filter |
| MP | mechanical polish |
| NA | non applicable |
| NaOH | sodium hydroxide |
| NFPA | National Fire Protection Association |
| NR | not recommended |
| OSHA | Occupational Safety and Health Administration |
| ORP | oxidation reduction potential |
| OQ | Operational Qualification |
| P | possible |
| PEEK | polyether ether ketone |
| PFA | perfluoralkoxy alkanes |
| PI | pressure indicator |
| PIT | pressure indicator and transmitter |
| POU | point of use |
| PPP | PW/WFI pretreatment and production |
| PQ | Performance Qualification |
| PS | pure steam |
| PTFE | polytetrafluoroethylene |
| PVC | polyvinyl chloride |
| PW | Purified Water |
| QIT | quantity indicator and transmitter |
| R | recommended |
| RO | reverse osmosis |
| SBS | sodium bi sulfite |
| S&D | Storage and Distribution |
| SOP | standard operating procedure |
| SPRO | single pass reverse osmosis (RO) |
| SS | stainless steel |
| TC | Tri Clamp |
| TDS | total dissolved solids |
| TIG/GTAW | Tungsten Inert Gas/Gas Tungsten Arc Welding |
| TT | temperature indicator |
| TOC | total organic carbon |
| UF | ultrafiltration |
| URS | User Requirements Specifications |
| USP | US Pharmacopeia |
| WFI | Water for Injection |
[1] | Pharmaceutical Engineering Guide ISPE Volume 4: Water and Steam Systems, December 2011 | |
[2] | ASME BPE-2014 Bioprocessing Equipment, October 2014 | |
[3] | European Pharmacopoeia 9th edition, January 2017 | |
[4] | The Japanese Pharmacopoeia 17th edition, March 2016 | |
[5] | US Pharmacopeia Convention USP 39, May 2017 | |
[6] | FDA CFR 21 (food and drugs) part 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES, April 2017 | |
[7] | Volume 4, GMP, Mechanical Products for Human and Veterinary Use Annex 11: Computerised System, January 2011) | |
[8] | ASTM D 6908-03 Standard Practice for Integrity Testing of Water Filtration Membrane Systems | |
[9] | ISPE-Handbuch, Herstellung von Wasser für Injektionszwecke ohne Destillationsverfahren, 1. Auflage 2019 |