Tofflon, one of the largest pharmaceutical freeze dryer manufacturers in the world along with its Indian marketing and distribution partner Raj International will be organising a one-day seminar in Hyderabad and Ahmedabad on July 27 and 29 respectively. The seminar on the latest lyophilization solutions for Indian aseptic processing of sterile drugs is organised with an aim to ensure that India could leverage from the great opportunity of a booming global generics market with increasing contract manufacturing opportunities for MNCs and generics players.

In this seminar, the lyophilization solutions will cover information on the freeze dryer auto loading systems of vials and API's. It will deal with the principles of freeze dryer auto loading system, fixed (row-by-row) system, flexible (AGV) system, mixed systems and API auto loading systems. It will also focus on the methodologies of selecting an auto loading configuration, containment options, facility considerations and process considerations.

Speaking about the seminar, Jwalant Rana, CEO, Raj International, said, “With each opportunity comes a challenge and only the latest and most competitive technology will help the Indian industry to stay ahead of the competition. Our seminar is specifically focused on addressing the two very topical themes of 'automation and isolation' to help the Indian industry achieve this.”

He informed that the two considerations at the front of current aseptic process thinking are automation and isolation. The logic of minimising aseptic risk of contamination through human handling by utilising, automatic loading and unloading of freeze dryers is incontrovertible. In vial based production of lyophilized injectables, row-by-row automatic loading/unloading system, AGV automatic loading/unloading system, mixed automatic loading/unloading system integrated with barrier system (open-RABS, C-RABS or Isolator) with or without trays are all designed to assist Indian pharma achieve this.

These process improvements will also increase sterility assurance levels in the sale of sterile API’s into regulated markets and protect personnel from health and safety risks. Running in parallel with cost saving and risk recuing improvements in capital equipment.

Rana added, “Lyophilization process study is developed from trial and error approach to quantifiable/scientific approach. Tofflon is delighted to welcome BTL to illustrate how advanced scientific instrumentation can be applied to optimise lyophilization cycles and to improve lyophilization quality. We believe success in producing sterile lyophilized drugs is derived from both process and equipment.”

BTL a contract R&D and consulting company specialising in freeze-drying formulation and cycle process development will be offering competitive lyophilization solutions and will be working with the industry to grasp the opportunity and meet the challenge.