Quality Standards for Process Water in Animal Husbandry and Veterinary Experiments

Process water mainly refers to the water used in bottle washing and ingredient preparation processes in pharmaceutical manufacturing, and in the refining and washing processes in raw material drug production. According to water quality, it can be divided into drinking water, purified water (i.e., deionized water, distilled water), and water for injection. Each process should formulate its own water quality standards based on the process requirements.

(1) Drinking Water:

①Uses:

a. Initial washing of equipment, containers, and packaging materials for non-sterile drug production.

b. Water source for preparing purified water.

②Quality Standard: Complies with the drinking water standard GB5749-85

(2) Purified Water:

①Uses:

a. Initial washing of injection bottles, stoppers, etc.

b. Refining of non-sterile raw materials.

c. Ingredients for oral liquid preparations and external medications.

d. Water source for preparing water for injection.

②Quality Standard: Complies with the purified water quality standard in the *Veterinary Pharmacopoeia of the People's Republic of China*. An additional check is added for resistivity > 0.5 MΩ•cm (conductivity ≤ 2 μS/cm). (3) Water for Injection:

①Uses

a. Injection preparation.

b. Water for final bottle and stopper washing of injections (filtered through a 0.45 μm pore size membrane).

c. Refining of sterile active pharmaceutical ingredients.

②Quality Standards: Complies with the standards of the *Pharmacopoeia of the People's Republic of China for Veterinary Medicine*, resistivity > 1 MΩ•cm, pyrogen < 0.25 EU/ml, microorganisms < 10 CFU/ml.