Water quality can vary depending on the manufacturing stages, the final product produced or the standards applied. Here is the minimum quality of water accepted for the composition of pharmaceutical products.
| Potable water | Purified water | WFI (Water For Injection) |
| Initial rinse for products.
Final rinse for products (If the equipment is dried after rinsing with 70% alcohol, this should be diluted in the same quality water as that used for the final rinse). |
Water for sterilizing loads. | The “highly purified” quality of PPI water is accepted if justified and validated with depyrogenization following the final rinsing of the loads. |
| NON-STERILE Pharmaceutical | NON-STERILE Pharmaceutical
Pharmaceutical STERILE NON-INJECTABLE Products |
Pharmaceutical STERILE
INJECTABLE Products |
As the table can show, each level of water purity has its own application, the lower the quality, the more its usefulness in pharmaceuticals is restricted due to the standards and benchmarks in force. Conversely, high quality water will find more applications, until, upon reaching a certain quality level, it is qualified as PPI water and used in the composition of the most critical products.
STERIGENE and our partner STILMAS offer water production equipment. Depending on different processes, water purification can reach several levels, the highest in the pharmaceutical industry being that of water for injections (PPI water).
The processes may differ depending on customer expectations and needs, but it is very often composed of a water pre-treatment system which ensures premium quality to the outgoing water. This is followed by treatment by EDI to further improve its quality, then via one or more reverse osmosis, the water recovered is almost pure. A final treatment in a thermocompressor or distiller ensures PPI water.
