Drug Manufacturing White Paper

Cross-Contamination – How to Stay Compliant

Drug Manufacturing White PaperCross-contamination in drug manufacturing impacts product quality, and may even lead to product recalls. Hygienically designed weighing equipment helps prevent cross-contamination and ensures regulatory compliance.

Statistics on drug recalls from the U.S. Food and Drug Administration (FDA) show a significant increase in the last few years. Cross-Contamination is a key reason for recalls.

There are different opinions on the cause for the increased recalls. Most likely, it has been a combination of several factors, such as increased 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, such national and international bodies, as the FDA, European Medicines Association (EMA) and the World Health Organization (WHO) provide extensive guidelines in the form of Good Manufacturing Practices (GMP).

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. It must also be designed for easy and thorough cleaning.

Designed to avoid contamination

In addition, cGMP requires that the surface of the equipment must not lead to 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 critical with regard to cross-contamination risks, 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 weighing device facilitate easy and through cleaning.

Meet hygienic design standards

Hygienically designed scales, such as the PBA430 weighing platform or the IND890 weighing terminal prevent accumulation of contaminates by fulfilling international hygienic guidelines of leading organizations such as EHEDG and NSF. These include:

  • Stainless steel of high quality, for example type 304 or 316
  • Easily cleanable surface with a roughness below 0.8 micrometers
  • Quality of fasteners and welding – stitch welding is not acceptable
  • No sharp angles, holes, crevices, or folds and minimized horizontal surfaces to prevent accumulation of materials and facilitate easy, thorough cleaning.

Regulatory Compliance White Paper

Learn more about how to prevent cross-contamination and comply with regulations. A new white paper provides a comprehensive overview of weighing-related regulations in pharmaceutical manufacturing. Download it now:

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