Pharmaceutical and Laboratory solution

The importance of water for Pharmaceutical and Laboratory

Water use in pharmaceutical need to have these 2 properties

1. The purity of the water, The method to measure the quality of the ultra pure water is using its conductivity because pure water is Dielectric, when there are some impurities it will start to conduct. The less conductivity the more purity. Pure water can have conductivity up to 18.4 MΩ

2. Infection of water, The advantages of using pure water is there’s no food for bacteria to grow, therefore no bacteria will survive. Because if there are bacteria infected in the system it would take 48-72 hours to identify whether water is infected or not, which affects the product line or may lead to patient infection

Therefore Purity is the main principle of designing a pharmaceutical system which requires high experience company with knowledge of the operation process.

Type of water used in pharmaceutical industry

1. Purified Water is the main water use in pharmaceutical industry, equipment cleaning process, evaluation process, and some of this water are used as ingredients, we call this “Sterile Purified Water” which has added sterile process to the water, in which we use it as ingredient and clean high-quality equipment

2. Water for Hemodialysis is the water use in Hemodialysis machine which use as a medium to carry waste out of the human body via osmosis method through the human membrane. The water is Purified water that has been proved there’s no endotoxin

3. Water for injection, This type of water is the pinnacle of pharmaceutical and require the highest purity. Since the medicine have to be injected directly into the patient’s body, therefore it’s critical to remove all if the endotoxin which may cause problems to patient

4. Pure steam is the steam that use in many process of the factory which steam have to be pure sometimes steam can be use to eliminate endotoxin buy condence the steam, Pure steam involve in process of produce water for injection

Reference : USP [1231] WATER FOR PHARMACEUTICAL PURPOSES

Water standard

Parameter	Unit	Purified Water	Water for Hemodialysis	Water for Injection	Pure Steam
TOC	ppm C	≤ 0.5	≤ 0.5	≤ 0.5	≤ 0.5
Conductivity	µS/cm @ 25 C	≤ 1.3	≤ 1.3	≤ 1.3	≤ 1.3
Aerobic Bacteria	CFU/100 ml	≤ 10,000	≤ 100	≤ 100	≤ 100
Bacteria Endotoxin	EU/ml	–	≤ 2	≤ 0.25	≤ 0.25