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4 Tips to Minimize Contamination Risk in Your Pharmaceutical Steam System Process

08/09/2021

From vitamins to vaccines the global pharmaceutical industry is fundamental to enhancing the world’s health. It’s an important priority for pharmaceutical manufacturers to comply with stringent industry legislation, health, safety, and current Good Manufacturing Practices. When it comes to minimizing your contamination risk in your pharmaceutical steam system process, you need a steam system that’s designed, built and validated to deliver optimum performance. The four tips explained below can help you minimize contamination risk and achieve optimum performance in your pharmaceutical steam system process.

1. Use the correct and highest grade of steam for your pharmaceutical manufacturing process. 

Pure steam is the highest grade of steam and is required wherever the steam or its condensate comes in contact with pharmaceuticals. It is also used for thermal disinfection and sterilization processes.

Pure steam: 

  • Is prepared from purified water or water for injection, which is water pure enough to be injected into the human body with no adverse effects. When condensed the condensate meets the requirements and USP standards for WFI.
  • Is created in a dedicated generator designed, built, and operated in accordance with current Good Manufacturing Practice (cGMP) requirements, USP, ASME BPE, ISPE, and in accordance with FDA requirements.
  • Has been heated above 212o degrees Fahrenheit and vaporized in a manner that prevents source water entrainment.
  • Contains no added substances.
  • Meets specific requirements for bacterial endotoxins, total organic carbon, water conductivity, and dryness.

2.  Use steam system products that prevent bacterial growth, corrosion, and are hygienic stainless steel.

Products suitable for high purity systems must be designed and manufactured to a high standard to ensure compliance with the exacting rules and regulations set for the pharmaceutical industry, and should prevent bacterial growth, corrosion, and be made of hygienic stainless steel.  The availability of 3.1 material certificates, surface finish reports, typical test reports, certificates of compliance, and certificate of origin are of the utmost importance.

Some of these types of products include:

  • Pure and clean steam traps
  • Sanitary pressure control and instrumentation 
  • Sanitary ancillary products 

3.  Follow and comply with Current Good Manufacturing Practices (CGMP).

The Current Good Manufacturing Practice regulations are enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

4. Get regular steam system assessments

Steam plays a very important role in the manufacture of pharmaceuticals.  When it comes to minimizing your contamination risk in your pharmaceutical steam system process, it’s a must for you to be proactive in making sure that your steam system is operating at the highest possible standard to deliver optimum performance. Your system’s design and materials, your feedwater quality, and your operational and maintenance practices all affect steam quality and purity. That, in turn, affects the efficacy and safety of your end product. 

Spirax Sarco offers steam system assessments including audits, steam trap surveys, steam quality testing, and health and safety compliance.  If you’re concerned about your current steam system and need advice, your local Spirax Sarco sales engineer is available to help.  Get in touch today!

 

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