Water is one of the major commodities used by the Life Science Engineering. It may be present as an excipient, or used for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment, primary packaging materials etc.

APRO-TECH WE ADAPTS TO REQUIREMENTS OF THE EUROPEAN PHARMACOPOEIA

The European Pharmacopoeia provides standards for the following grades of water, in APRO-TECH provides solutions and complete systems for:

• Purified Water
• Highly Purified Water
• Water for Injections

• Potable Water is not covered by a pharmacopoeia monograph but must comply with the regulations on water laid down by the competent authority. Testing should be carried out at the manufacturing site to confirm the quality of the water. Potable water may be used in chemical synthesis and in the early stages of cleaning pharmaceutical manufacturing equipment unless there are specific technical or quality requirements for higher grades of water. It is the prescribed source feed water for the production of pharmacopoeia grade waters.
• Purified Water is water for the preparation of medicinal products other than those that require the use of water which is sterile and/or apyrogenic. Purified Water which satisfies the test for endotoxins may be used in the manufacture of dialysis. Purified Water is prepared by distillation, by ion exchange or by any other suitable method, from water that complies with the regulations on water intended for human consumption laid down by the competent authority.
• Highly Purified Water is intended for use in the preparation of products where water of high biological quality is needed, except where Water for Injections is. Highly Purified Water is obtained from water that complies with the regulations on water intended for human consumption laid down by the competent authority. Current production methods include, for example, double-pass reverse osmosis coupled with other suitable techniques such as ultrafiltration and deionization. Highly Purified Water meets the same quality standards as WFI but the production methods are considered less reliable than distillation and thus it is considered unacceptable for use as WFI
• Water for Injections (WFI) is water for the preparation of medicines for parenteral administration when water is used as a vehicle (water for injections in bulk) and for dissolving or diluting substances or preparations for parenteral administration before use (sterilized water for injections).

Control of the chemical purity of WFI presents few major problems. The critical issue is that of ensuring consistent microbiological quality with respect to removal of bacteria and bacterial endotoxins. Distillation has a long history of reliable performance and can be validated as a unit operation; hence it currently remains the only official method for WFI.

WFI in bulk is obtained from water that complies with the regulation on water intended for human consumption laid down by the competent authority, or from purified water, by distillation in an apparatus of which the parts in contact with the water are of neutral glass, quartz or suitable metal and which is fitted with an effective device to prevent the entrainment of droplets. The correct maintenance of the apparatus is essential. During production and storage, appropriate measures are taken to ensure that the total viable aerobic count is adequately controlled and monitored.

The USP (United States Pharmacopeia) defines this as highly purified waters containing less than 10 CFU/100 ml of Aerobic bacteria. These waters should also have fewer than 500 ppb of total organic carbon, fewer than 0.25 EU/ml endotoxins, and a conductivity of less than 1.3uS/cm @ 25 C.

APRO-TECH belongs to an industrial group focusing on areas of engineering, services and equipment for the life science industry, with an international presence. Our main objective is to provide the best solutions to client’s needs and perspectives in the pharmaceutical and related industry, in order to obtain customer satisfaction and business continuity.

APRO-TECH, your partner in Life Science Engineering, Clean Room, Process, HVAC, Validation, Project Management…