Water for pharmaceutical use

Productos Farmacéuticos, Biotecnológicos y Afines

INDEX

Introduction

Qualities of Water

Purified Water

Potable Water

Water for Injections

Conclusion

Bibliography

Daniel Valle Peris

Water for Pharmaceutical Use

Its regulations

Introduction

The importance of water in the pharmaceutical industry

Water is one of the fundamental resources in the pharmaceutical industry, playing a vital role in both the production and quality assurance of products. Its applications include use as an solvent, excipient, cleaning agent, and in processes such as manufacturing, synthesis, analysis, and storage.

To achieve the qualities of water for pharmaceutical use, it is necessary to remove contaminants from potable water based on the risk to the final product.

qualities of water

Water for Injections (WFI)

Purified Water (PW)

Potable Water

Potable Water

It is used as the initial source for the production of pharmacopeia-grade water and in the early stages of cleaning and chemical synthesis

Requirements

Potable Water

What is it?

Water that meets the quality requirements for human consumption established by the laws of each country.

Main Uses

It must be monitored at the manufacturing site to ensure compliance with applicable standards. Although it does not have a specific monograph in the European Pharmacopeia, it is crucial as a primary raw material.

Obtained through processes such as reverse osmosis, deionization, filtration, or combinations of these techniques.

Production

Purified Water

What is it?

Water treated to remove chemical and microbiological contaminants, not intended for applications requiring sterility or apyrogenicity.

Main Uses

Used in non-sterile medicines, topical products, and some dialysis solutions, provided it meets the endotoxin limits defined by Ph Eur.

Can be obtained by distillation or equivalent processes such as reverse osmosis combined with ultrafiltration.

Production

Water for Injections (WFI)

What is it?

High-purity water intended for the preparation of parenteral medicines and other applications requiring sterility and apyrogenicity.

Main Uses

Indicated for parenteral solutions, dialysis solutions, irrigations, and biological medicines. It is also used in cleaning processes where a higher purity level is required.

Conclusions

Pharmaceutical-grade water is a critical resource whose control and management directly impact the safety and efficacy of medicines. Compliance with international standards and quality specifications ensures that pharmaceutical products meet the required standards for safe use.

BibliogrAphy

European Medicines Agency. (2018). Guideline on the quality of water for pharmaceutical use (EMA/CHMP/CVMP/QWP/496873/2018). Retrieved from https://www.ema.europa.eu

USP

Ph Eur

This presentation will discuss the European (Ph Eur) Pharmacopeia.

pharmacopoeias

The different qualities and their standards are defined in pharmacopeias, which are similar to each other but with some significant differences.