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GMP Cleaning, Isolation and Decontamination Systems for the Pharmaceutical Industries.



// November, 2021


With an ever increasing global population across all sectors and the ability to diagnose with increased accuracy diseases such as cancer, our society is looking to the pharmaceutical industry to develop and produce pharmaceutical’s that can treat or cure these conditions.

They are also looking for a steady and robust supply network which can be made accessible to all markets.

Emerging markets such as India, China and Middle Eastern Regions are now accounting for the fastest growth rates in Cancer related diagnoses. According to WHO, developing regions accounted for over 66% of all cancer related deaths in 2014.

The rate of percentage growth around new cancer cases in Asia between 2012 to 2020 was up by 24% (6.8m to 8.4m). This trend is not slowing and will continue to increase as our ability and accessibility to current and future methods of diagnoses tools evolve.

If we specifically consider the HPAPI (High Potency Active Pharmaceutical Ingredients) segment of the pharmaceutical manufacturing industry, this sector has continuously grown production yield about 7% per year since 2005 to 2019, HPAPIs are estimated to have an annual growth of 12% over the same period and this now accounts for about 12% of the total pharmaceutical market.

To support the fight against disease related threats, the utilisation of High Potency Active Pharmaceutical Ingredients (HPAPI) is vital.

As an ingredient for many drugs which are linked to cancer treatments, the methods utilised for the handling of HPAPI’s is tightly controlled and managed with specialised containment methods.

This is essential to shield workers and the surrounding areas from exposure related events, due to the hazardous nature of these API’s.

In most instances, specifically designed HPAPI manufacturing facilities are being built due to the unique and complex handling requirements.

This is the vital link for the Industry and IWT Cleaning Excellence, with the simple question of how to manage and maintain correct standards of cleaning that can be supported with a validated system yet offer the user the required levels of safety to ensure a safe working environment?

As a globally recognised leader in the manufacture of cGMP related cleaning systems, IWT has developed, via close working partnerships, a system that can ensure correct worker shielding from accidental HPAPI exposure.

All this whilst offering a cleaning process which can be specifically tailored towards the needs of the application without size of part or design complexity being a limiting factor.

Solutions range from small component part washers which utilise pressurised seals and gaskets to limit any air exchange between environmental facility zones through to Large IBC/Bulk containment washing skids that can offer autonomy for works when manipulating parts to be made ready for washing.

An IWT cleaning system is more than a conventional component washing machine and the industry which we serve has facilitated this technical evolution due to the unique demands of applications such as HPAPI’s.

If we look specifically at the cleaning of IBC style mobile storage vessels, these containers are available in storage sizes ranging from 50 – 1000ltr and are commonly equipped with a containment valve system that demands a specific manipulation to actively open and close the valve.



Our current range of IBC/Bin washing systems can now be equipped with a fully automatic solution which will ensure user safety during this critical phase of cleaning. Additionally, the IBC washer can also accommodate smaller component styled parts which would often demand a dedicated Part washer styled solution.

Our history and expertise of customised basket solutions can ensure we are able to design and manufacture the basket in a manner that offers total critical surface area wash coverage and minimal part shadowing effects (part shadowing is the common effect that is created when a component supported in a customised basket is in direct surface contact with the application, resulting in areas being obscured from direct wash action).

As a basic conclusion, the development and manufacture of HPAPIs requires significant planning, extensive training, proper equipment, and facility design as well as implementation of the necessary procedures to safely handle the compounds. The investments are significant, and the knowledge gained through experience is invaluable.

IWT Cleaning Excellence is  best placed to support this evolving market. The experiences and successes we have created globally will continue to help support our partners in the industry.

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