Water is a fundamental component in the production of many medicines and pharmaceutical products. There are different types of water used depending on the application, each with specific characteristics that ensure quality and suitability for use.
Types of water
Let us take a closer look at how many and which types of water are used in the production of medicines and products in the pharmaceutical industry:
Purified Water (PW): used in the production of liquid medicines and in the preparation of solutions for parenteral use.
Sterilised Water (SW): used in the production of sterilised medicines and sterile parenteral solutions.
Water for Inhalation (AWFI): used in the production of medicines for inhalation and nebulisers.
Water for Dialysis (WFI): used in the production of medicines for dialysis and in haemodialysis.
Demineralised Water (DM): used as a support solution in certain pharmaceutical applications.
Regulations to be aware of
In conclusion, each type of water used in the pharmaceutical industry must meet strict quality and purity standards to ensure the safety and effectiveness of the medicines produced.
In the pharmaceutical sector, the use of different types of water is regulated by specific standards.
Below are some of the main regulations covering this topic:
United States Pharmacopeia (USP) – defines the requirements for the purity and quality of the different types of water used in pharmaceutical manufacturing, including Purified Water (PW), Sterilised Water (SW) and Water for Inhalation (AWFI).
European Pharmacopoeia (Ph. Eur.) – defines the requirements for Water for Dialysis (WFI) and Demineralised Water (DM) used in pharmaceutical manufacturing.
Good Manufacturing Practice (GMP) Guidelines – provide guidance for the production of safe, high-quality medicines and pharmaceutical products, including specifications for the use of different types of water.
Regulation (EU) No. 536/2014 – sets out specifications for the manufacture of medicinal products for human and veterinary use, including requirements for the use of water at different stages of the production process.
These regulations ensure that the different types of water used in pharmaceutical manufacturing are pure and meet the quality requirements necessary to guarantee the safety and effectiveness of the medicines produced.
