Prabhaharan Sankaran, Technical Account Specialist, West Pharmaceutical Services, India, talked about his company’s product, 4040/40G LyoTec stoppers that bring an aided layer of risk mitigation to any lyophilisation process. “We have followed QbD principles for the 4040 LyoTec stoppers. We have gathered the user needs from the market as well as from the patients in order to create the user requirement for the specific design of the stopper. We have also designed the systematic and science-based approach in order to develop the formulation, design the component as well as the manufacturing capabilities. With this QbD, we were able to achieve identification and can figure out as well as improve the critical process attributes for our component. In addition, by doing statistical analysis, we were able to keep on improving our product process throughout the development journey,” he told the audience.
Talking about the features of the product, he said that LyoTec stoppers do not stick to Lyo shelves unlike other stoppers and prevent adhesion to the pressure plates of lyophilisation chamber. Further, these have ultra-low extractables and leachables and optimised drying properties, along with a high compatibility with steam sterilisation or gamma radiations.
Referring the US FDA Code of Federal regulations, 21 CFR 21194, he said, “Drug product containers and closures shall not be reactive, additive or absorptive, so as to alter the safety, identity, strength, quality or purity of the drug beyond the official or established requirements.”
He informed that 4040 LyoTec stoppers reduce one’s inherent packaging risk through ultra-low extractables and leachables – without a fluoropolymer barrier.
He also informed that West’s deep elastomer expertise and QbD approach to development of the 4040 portfolio has focussed on mitigating risk from raw material selection of the formulation to the final product.
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