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Need to know: a guide to sterilisation

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With the increased amount of biological products coming to the market, new practices to provide greater assurance on pharmaceutical sterilisation processes are necessary. At the same time, however, changes in the types of materials and products are forcing changes in typical sterilisation methods.

Sterilisation technologies:

A pharmaceutical product, based on the nature and the dosage form, can be sterilised using different methods and techniques.

The sterilisation market has dynamically improved from moist heat sterilisation (steam) to the progressive Ethylene Oxide (EtO), gamma radiation and low temperature gas plasma sterilisation, and finally to recent technologies like NO2-based sterilisation.

Steam/moist heat sterilisation, despite being the oldest method, is still the most preferred in a healthcare setting due to its ease of use and low costs as compared to low temperature sterilisation.

E-beam and low-temperature hydrogen peroxide gas plasma (LTHPGP) sterilisation techniques are gaining popularity over conventional methods due to various advantages conferred by them.

The role of sterilisation in medical packaging has been of crucial importance, especially of finished products like saline bottles, needles, syringes, etc. In life sciences applications like research laboratories, steam sterilisation (autoclaves) is widely practiced to avoid any decontamination of media, culture, equipment, and glassware.

Hence, with a wide array of applications, the sterilisation market is expected to foresee a stable growth in the coming years.

Major equipment/processes used for sterilisation:

Several specialised equipment are used in different types of sterilization technology:

Market Info:

The United States leads the global market with a share of 29% closely followed by Europe with 27%, during 2014–2020. Filtration, was the leading technology for sterilisation in 2014 with US$2.7 billion of the total $4.8 bn.

Biologics lack viable options for sterilisation due to their very delicate and complex properties and hence cannot be terminally sterilised. This has helped the adoption of fi ltration technique in the industry.

High potency drugs — which comprise small molecules, complex biologics and combinations of both — are growing at a faster pace than the industry average globally. Requirement of specialised containment facilities for high potent compounds is contributing to the growth of the outsourcing sterilisation market.

Need of Contract Sterilisation Service Providers:

The sterilisation services industry has been growing at a healthy growth rate in the past decade. Rising incidences of infections and the need for state of the art containment facilities for handling drugs to avoid regulatory compliance issues, has led to the growth of both onsite as well as offsite sterilisation services. The offsite sterilisation market is growing faster than its predecessor. The improving healthcare infrastructure in many of the emerging Asian countries has also contributed to the growth of the industry.

Following reasons have led to the outsourcing of sterilisation activities to third-party agencies:

Piramal Pharma Solutions, which supplied this guide, provides sterilization services for sterile liquids, lyophilised parenterals and injectables, ADCs and High potent APIs through specialised containment facilities and suitable experience in various sterilisation technologies.

References:

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