PHARMACEUTICALS that operatives can minimise the time required to clean and validate equipment across maintenance routines or changeover procedures . In recent years , containment equipment has evolved to become more effective and efficient , with next-generation single-use technologies ( SUTs ) emerging on the market .
SUTs & HPAPI containment
A number of SU versions of standard containment components are now available on the market . These are designed to be used once and disposed of , thus minimising the time spent on cleaning and validation procedures and reducing the risk of cross-contamination . One good example is the implementation of SU SBVs , which help facilities safely enhance their containment of highly potent ingredients with greater efficiency . SU SBVs are composed of two components : a stainless steel ‘ active ’ half , which connects to production line equipment and a single-use ‘ passive ’ half , which attaches to the filling container or primary packaging for the product . Once these components are connected , they create a single disc inside the valve , which allows the product to flow from the line into the container without any exposure to the surrounding environment or human operators , maintaining an uncompromised closed processing environment for highlevel containment .
These SU SBVs function in the same way as their stainless steel counterparts . However , because they are disposable , manufacturers can achieve greater levels of efficiency by minimising cleaning and verification between transfers . By eliminating the need to clean this equipment , the risk of contamination between transfers is significantly reduced because particles cannot become airborne during washdown procedures . As a result , this SUT helps manufacturers to ensure proper containment while remaining compliant with stringent regulations .
Future of containment
This advance in SUT is not the only way to ensure containment is maintained when handling HPAPIs . Hailed as part of ‘ Industry 4.04 ’, smart factory technology offers more ways for manufacturers to optimise their containment procedures across production lines . This technology is able to record usage data on SBVs and other components across production lines , supplying operatives with invaluable information into their health status . This information provides teams with necessary information , such as monitoring the use of components and alerting operators when a component is reaching the end of its usable life .
In doing so , it means that components are not used beyond their shelf life , ensuring optimum containment . Additionally , this technology allows production line operatives to better plan their maintenance procedures to help them minimise downtime and optimise productivity . Not only can this data deliver valuable safety insights , but it can also create an end-to-end audit trail across every process along the production line , enabling health and safety teams to demonstrate regulatory compliance during inspections .
Safety-first approach
The rise in the HPAPI market poses exciting opportunities for pharma companies as they look to the future . At the same time , harnessing these opportunities means they must explore methods of processing HPAPIs efficiently while maintaining optimum health and safety standards for employees and their local environment . Utilising innovative technologies to ensure that they can remain efficient across their processes while meeting compliance requirements is a must for manufacturers . By exploring SUTs and smart factory solutions , manufacturers can benefit from more convenient and enhanced containment controls , ensuring that HPAPIs can be safely handled to deliver life-saving treatments to patients . •
Mike Avraam
DIRECTOR OF APPLICATIONS & SOLUTIONS ENGINEERING
CHARGEPOINT TECHNOLOGY k + 44 151 728 4500 J mike . avraam @ thechargepoint . com j www . thechargepoint
References :
1 : https :// www . ihealthcareanalyst . com / global-highly-potent-activepharmaceutical-ingredients-market /
2 : https :// www . who . int / teams / health-product-and-policy-standards / standards-and-specifications / gmp
3 : https :// www . ema . europa . eu / en / news / two-additional-countriesbenefit-eu-us-mutual-recognition-agreement-inspections-0
4 : https :// www . sciencedirect . com / science / article / pii / S0378517321003598
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