Clean-in-place (CIP) in Pharmaceutical Manufacturing

August 27, 2018

Pharma

Clean-in-place (CIP) is a cleaning method used mainly in the pharmaceutical manufacturing industry. CIP can be implemented to clean vessels, interior surfaces of pipes, filters, process equipment, and fittings, without disassembly.

The water used to clean pharmaceutical production equipment must be as high quality as the water used for production. This means purified water capacity must be sufficient to meet the needs of cleaning, in addition to production volume. Typically, systems are also taken apart twice a year for cleaning, utilizing chemicals stronger than those of the typical CIP cleaning cycle.

Water purification system components that require water for pharmaceutical manufacturing processes are determined by need and by the feed water’s quality. When employing a CIP system, testing of the feed water is required to accurately identify contaminants it may contain, including particulates, inorganics, organics and microorganisms. The contaminants present determine the technologies required for the water purification system design. A typical system that produces purified water may require three stages:

  • Pretreatment, consisting of filtration to remove particulates and some organics, and de-chlorinization to remove chlorine added by the municipal water treatment system. Chlorine will degrade stainless steel over time and therefore must be removed from the water before the water enters the pharmaceutical production equipment. Activated carbon filters are typically used to remove chlorine, which can also damage reverse osmosis (RO) membranes over time. Sediment filters may be used to remove particulates.
  • Final treatment, in which the water is purified via ion exchange, RO, electro deionization, or a combination of methods. Disinfection methods include RO and continuous electro deionization (CEDI), which uses electricity, ion exchange membranes, and resin to deionize water. CEDI does not require the use of chemical treatments.
  • Polishing steps, including electrodeionization (EDI), which is usually a polishing treatment to RO. Continuous EDI units use the electric current to regenerate the resin mass continuously. This technique can achieve very high purity, with conductivity below 0.1 µS/cm. Ultraviolet light systems leave no residue in the water and deactivate the DNA of bacteria and viruses that may be present. A typical WFI production system consists of a water purification system, distillation equipment, and storage tanks specifically for WFI.

As an integration company with over 30 years of pharmaceutical industry experience, Grantek provides end-to-end services to ensure our customers’ purified water systems are installed and integrated into the facility in accordance with current industry standards.

While Grantek does not build our own water purification systems, we integrate them into our client’s processes and their facilities. We are a pharmaceutical integrator focusing on systems automation with strengths including working with a deep network of partners with expertise throughout the pharmaceutical manufacturing industry. In addition to integration and automation, Grantek offers extensive experience in development of project lifecycles, validation and qualification documentation. We perform fully documented facility acceptance testing, site acceptance testing, and IQ/OQ/PQ testing, providing our customers with a validated system and the full complement of required documentation.

Please contact Grantek to request any information you may need for your purified water system, or any pharmaceutical system. We look forward to the opportunity to share our expertise and learn about your needs.

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