Synthesis and Dispensing HPAPI Containment.

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Synthesis and Dispensing isolators

Synthesis and dispensing in the pharmaceutical industry are certainly important phases where reliability and precision matter, but when high-potent substances are involved, safety matters even more.

Synthesis and dispensing, isolator cleaning steps and all the other operations inside glove boxes require close attention, especially in the HPAPI sector. Attention that CSV Containment pays right from the design phase, thinking not only about the best solutions to ensure the safety of operators and products, but also about ease of use and ergonomics. For this project intended for the research and development area of a major company in the pharmaceutical world, other CSV Life Science Group companies were involved: Pharma Hub & Officine Galesso. From this collaboration, it has been realized a stand-alone ATEX skid for preparation and pumping of washing, which enables convenient CIP operations.

GMP & safety recovery time

All the chambers are in C grade, due to GMP requirements. CSV Containment wanted to go further and in addition, to always ensure synthesis and drying chambers inertization, has included a specific cycle with alternating air and nitrogen flows that protect the safety of operators and synthesis processes in the chambers. When the pre-chamber and post-chamber have to be opened, the nitrogen input stops and a “wash” cycle time with compressed air is set. This operation eliminates the nitrogen in the chambers and prevents the operator from breathing it, as it is harmful to health. After working with “air”, when the doors close, a GMP recovery time cycle is reactivated, bringing the chamber back to C grade due to clean air. In the second step, nitrogen is automatically restored so that an inert environment can be ensured even when the inner doors are opened.

From design to final validation

But the attention to the client does not stop only at the design stage. Following the philosophy of the Group to which it belongs, CSV Containment accompanies the client from the early design stages to final validation, trying to adapt its work to the challenges that environments present. Even in the case of these isolators, CSV Containment realized the best possible solution to meet the client’s needs, counting on the group’s support. CSV Containment as always has ensured the testing phases, starting from leakage tests to SMEPACs, as well as validation, thanks to the qualified team of CSV Life Science Group. On the other hand, for the isolator construction, CSV Containment has been able to rely on the Group’s two workshops, one in northern and one in central and southern Italy, which can more effectively serve and assist the different realities of the Pharma world. Finally, several accessory elements to the isolators were produced in-house, starting with the continuous liners dedicated to the bag-out of the machines.

Dispensing Isolator, main features:

  • ATEX pre-chamber and dispensing chamber with Jugitec EPDM gloves.
  • HEPA “push-push safe change system” class H14 filters in supply and exhaust
  • O2 monitoring in the dispensing chamber and external isolator with Endress+Hauser sensors
  • IP 65 internal isolator – CFR 21 Part 11 compliant – Full GMP standards
  • OEB6 band certified with SMEPAC monitoring
  • WIP system with spray ball and spray gun for each chamber
  • Process contact parts in AISI 316L, frame and non-contact parts in AISI304
  • Two DN 300 Continuous liners in the dispensing chamber with 150 mm canister in AISI 316 and dedicated inner door
  • TP 1200 HMI panel for equipment monitoring
  • Recipes programmable and recallable from the panel
  • Data acquisition and the possibility to interface the system with the company BMS
  • Vacuum Dryer ATEX – 50 lt
  • Two Mettler-Toledo scales with display and printer

Synthesis isolator for an HPAPI development laboratory

The synthesis isolator consists of inlet, synthesis, drying, and outlet chambers. All the chambers are ATEX.

Main features:
  • All chambers are equipped with Jugitec conductive EPDM gloves.
  • All seals and gaskets are made of conductive EPDM.
  • IP 65 internal isolator – CFR 21 Part 11 compliant – full GMP standards.
  • OEB6 band certified with SMEPAC monitoring.
  • Process contact parts in AISI 316L, frame and non-contact parts in AISI304.
  • Internal surface of synthesis chamber coated with anti-acid treatment.
  • HEPA “push-push safe change system” class H14 filters in supply and exhaust
  • O2 monitoring in each chamber and external isolator by Endress+Hauser sensors
  • Chambers equipped with spray-gun with PTFE hose and spray-ball
  • TP 1200 HMI panel for equipment monitoring
  • Recipes programmable and recallable from the panel
  • Data acquisition and the possibility to interface the system with the company BMS
  • Isolator equipped with one DN 300 Continuous liner in the synthesis chamber and one in the exit chamber. The liners are supported by an AISI 316 canister for material exit and access to liners from inside via dedicated doors
  • Mettler-Toledo scale on display and printer

CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: containment@csv-ls.com

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