PHARMACEUTICALS
Challenge of containment
HPAPIs provide many benefits to patients when administered in smaller doses . However , their highly potent ingredients must be handled carefully to avoid inflicting unintended adverse effects on production line operators , as well as on the environment surrounding any facility handling them . To prevent this and minimise the risk of contamination , every stage of handling these drugs must be done in a contained environment . Engineering controls must be implemented to prevent the release of particulates into the atmosphere , as well as ensure safe disposal of any waste materials after manufacturing . Failure to ensure stringent containment measures when handling HPAPIs can lead to various negative effects for operators who are exposed to them . These may include skin sensitising effects , hormone overproduction , or more severely , respiratory problems and even anaphylaxis . Depending on the HPAPI a person is exposed to , this can lead to other acute and chronic conditions over time , which can be life-threatening .
Drug manufacturers must also tailor their disposal measures to the specific nature of the HPAPI materials being processed to ensure that they are not released into the environment , either via the water system or into the atmosphere , via rigorous ventilation measures and sealed containment systems . If this were to happen , it could cause widespread damage to wildlife , plants and human populations .
Legal requirements
With the potential for such severe consequences , government inspection authorities monitor facilities handling HPAPIs closely for signs of control breaches . If found to be non-compliant , drug manufacturers can face serious legal and financial penalties , suffer reputational damage , and have their facilities shut down . There are numerous guidelines and regulations manufacturers must follow to ensure the safe handling of highly potent materials . GMP guidelines set out a minimum standard that manufacturers must follow , but there is also legislation in place to ensure manufacturers properly contain their handling of HPAPIs . 2 The European Medicines Agency is also working closely with the FDA to reach mutually agreed inspection standards to a level of equivalence between the two regions . 3
Overcoming containment challenges
Traditional containment solutions have been used within CDMOs for many years , but these technologies have had to evolve and develop in order to meet changing manufacturing requirements , leading to inefficiencies in handling and containment performance . These traditional solutions involved containment within cleanroom environments , thorough cleaning regimes , and strict management of airflow to ensure highly potent materials are safely ventilated . Closedsystem containment processes must be implemented via components such as split butterfly valves ( SBVs ) that ensure the safe and contained transfer of powders into and out of processing equipment , containers or bags . It is crucial for this containment technology to remain easy-touse , install , clean and replace , so
32 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981