Cross-contamination in drug manufacturing leads to product recalls. Hygienically designed weighing equipment helps prevent cross-contamination and ensures regulatory compliance.
- Download white paper on Pharma regulations
- Learn about the hygienically designed IND890 terminal
- Learn how the PBA430 scale facilitates easy cleaning
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Statistics from the U.S. Food and Drug Administration (FDA) have shown a significant increase in drug recalls in the last few years. Cross-contamination is one of the key reasons for recalls. Opinions differ about the reasons the number of recalls have increased so strongly. Most likely, it is a combination of several factors, such as greater scrutiny by the FDA and other authorities and the globalization of the drug manufacturing business that splits responsibility for different manufacturing steps between various companies around the world.
Key regulations
When it comes to prevention of cross-contamination, several national and international bodies, such as the FDA, European Medicines Association (EMA) and the World Health Organization (WHO), provide extensive guidelines in form of Good Manufacturing Practices. The FDA cGMP, for example, states that "Equipment used in the manufacture … of a drug product shall be of appropriate design … to facilitate operations for its intended use and for its cleaning and maintenance" (FDA 21 CFR Part 211, Sec. 211.63). The equipment must not only be designed to perform its task in the production process but, equally important, it must be designed so it can be cleaned easily and thoroughly.
Designed to avoid contamination
In addition, cGMP requires that the surface of the equipment must not lead to a contamination of the drug product. Specifically, it states that "Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product …" (FDA 21 CFR Part 211, Sec. 211.63).
Weighing instruments often play a central role in applications that are critical with regard to cross-contamination risk, such as dispensing and formulation. Therefore, when selecting the right weighing equipment for critical applications, it is important to consider how the design of the scale facilitates easy and thorough cleaning. Hygienically designed scales, notably the PBA430, prevent accumulation of contaminants and can be cleaned effectively and efficiently.
A new white paper provides a comprehensive overview of weighing-related regulations in pharmaceutical manufacturing.