The Pharmaceutical Post 2 (52/84)

The Pharmaceutical Post 2The Pharmaceutical Post 2 IMA LIFE / ARAYMONDLIFE montrent de manière concluante que l’introduction d’un tel CCS doit s’ac- compagner de validations qui quanti- fient les différences entre les variables du procédé de lyophilisation telles que le débit massique et la température du produit. Mener une stratégie d’essais proactive peut potentiellement éviter la perte d’un lot entier de produit lyophi- lisé lorsque la température du produit est proche de la température d’effon- drement (collapse) de la formulation. La différence de Kv aura également un impact sur la durée du cycle de lyophi- lisation lors du passage d’un lyophilisa- teur vers un autre. En outre, cette expérience confirme également la possibilité de fermer directement les flacons sur les étagères du lyophilisateur, d’assurer l’intégrité de la fermeture des flacons (Contai- ner Closure Integrity) et d’éliminer l’utilisation d’une station de sertissage transfer gets introduced when stoppers are switched even for the same vial type. Overall, the data generated in this study unequivocally shows that newer press-seal stoppers/CCS can significantly impact the process variables like mass flow and pro- duct temperature. Therefore, these preas- sembled stoppers/CCS should be employed in an aseptic freeze drying process only after thorough evaluation of lyo process variations. Conclusions Emergence of newer press-seal container closure systems (CCS) wi p-asse - bled rubber stopper and plastic cap is a significant effort towards optimization of parenteral drug manufacturing operation. In such CCS, capping is achieved by the application of simple vertical pressure during the stoppering step inside a freeze dryer. Elimination of the crimping opera- tion via these CCS generates cost saving in an aseptic fill to finish operation by allowing the process to be fully contained inside closed systems like isolators and res- tricted access barrier systems (RABS). However, the experimental data discussed in this white paper conclusively shows that that introduction of such CCS should be 52The Pharmaceutical Post 02 / supplémentaire et tous les coûts qui y zation process, PDA J Pharm Sci Tech, sont associés. 2010, 64 (6), 507-16. 7. Pikal MJ, Shah S, Mass and heat References transfer in vial freeze°drying of phar- maceuticals: Role of the vial, J Pharm 1. Birrer GA et. al. p 267 - Chapter 7, Sci, 1984, 73 (9), 1224-1237. Separation Science and Technology in 8. The pharmaceutical vial capping Handbook of Modern Pharmaceutical process: container closure systems, cap- Analysis, 2001. ping equipment, regulatory framework, 2. Outlook for global medicines and seal quality tests – Roman through 2021, IQVIA MIDAS. Matheas and all – European Journal of 3. Lyophilization in Pharmaceutical Pharmaceutics and Biopharmaceutics, Market Forecast 2019-2029, BCC 99 (2016) Research, February 2019. 4. US FDA Chapter 56. Cet article a été rédigé par l’équipe Life 5. Palmer E, Compatibility and testing Technology d’IMA constituée de pro- of nested container and closure systems fessionnels hautement qualifiés et dotés to help pharmaceutical companies ma- d’une grande expérience acquise dans le nufacture parenteral medicines, Fierce domaine du développement de produits Pharma, February 16, 2016. et de procédés parentéraux, avec le soutien technique et R&D du laboratoire 6. Mungikar A et. al. Effect of the de développement lyo LAB4LIFE situé design of the stopper including dimen- sur le site de production d’IMA Life en sion, type, and vent area on lyophili- Amérique du Nord (Etat de New York). accompanied by a qualification strategy nested container and closure systems to that quantifies the differences in lyo help pharmaceutical companies manufac- process variables like mass flow and pro- ture parenteral medicines, Fierce Pharma, duct temperature. Such proactive testing February 16, 2016. strategy can potentially save loss of an 6. Mungikar A et. al. Effect of the design of entire batch of freeze dried product when the stopper including dimension, type, and product temperature runs close to the for- vent area on lyophilization process, PDA J mulation collapse temperature. The diffe- Pharm Sci Tech, 2010, 64 (6), 507-16. rence in Kv will also impact the scale-up of 7. Pikal MJ, Shah S, Mass and heat transfer the existing freeze drying cycle from one in vial freeze°drying of pharmaceuticals: dryer to another. Role of the vial, J Pharm Sci, 1984, 73 (9), Additionally, this experiment also confirms 1224-1237. the possibility to directly close the vials 8. The pharmaceutical vial capping pro- on the lyo shelves, ensure a proper CCI cess: container closure systems, capping (Container Closure Integrity) and eliminate equipment, regulatory framework, and the use of an additional crimping station seal quality tests – Roman Matheas and all and all the cost associated with it. – European Journal of Pharmaceutics and References Biopharmaceutics, 99 (2016) 1. Birrer GA et. al. p 267 - Chapter 7, The article was written by the IMA Life Separation Science and Technology in Technology Team which includes a num- Handbook of Modern Pharmaceutical ber of highly skilled professionals, with Analysis, 2001. extensive experience gained in the field of 2. Outlook for global medicines through parenteral product and process develop- 2021, IQVIA MIDAS. ment, technical support and R&D at the 3. Lyophilization in Pharmaceutical Mar- LAB4LIFE Development Lyo Laboratory ket Forecast 2019-2029, BCC Research, located at IMA Life North America (NY) February 2019. manufacturing facility. 4. US FDA Chapter 56. 5. Palmer E, Compatibility and testing of Juin - 2020