Background

PG Freeze Drying Consult was founded 1st. July 2007.

 

Palle Gregersen, owner of PG Freeze Drying Consult, is having his original background from the Danish dairy industry but in the past 25 years he has been working within the pharmaceutical and biopharmaceutical industry both as a manager and a specialist and expert within freeze drying of drug substances and drug products.

I have been employed and worked at the companies Pasilac A/S (DK), Express Foods LtD (US), Pasilac Inc. (US) and Niro Inc. (US) of what 7 years was in USA, installing, starting up and servicing membrane filtration equipment (UF/MF/RO) especially within the chemical, pharmaceutical and biopharmaceutical industry.

I have been employed and worked as a department manager for 13 years at Xellia (DK). Here I gained thoroughly knowledge and competencies about design, qualification and validation of aseptic fully automated load/un-load bulk freeze drying and other vital process systems like autoclave, dry-heat sterilization equipment, sterile filtration of liquid and gases, CIP/SIP, finishing and handling freeze dried aseptic powders by sieving, milling and micronization as well as packaging and handling aseptic bulk material.

I have been employed and worked as freeze drying specialist and expert Novo Nordisk A/S (DK). Here I gained thoroughly knowledge and competencies about design, qualification and validation of freeze drying plants and freeze drying processes for both drug substances and drug products. I have professional experience with optimization of freeze drying processes increase of batch sizes, optimization of the freeze drying process to gain capacity and to cut down on energy consumption, optimization of CIP cycles to reduce water and time consumption. I have used LEAN as a tool in some of those assignments.

I have thorough experience and competencies within regulatory and customer audits gained through directly and active involvement in audits and inspections by agencies like FDA, LMS etc.

Also I have thorough experience and competencies within the preparation and the making of validation and process documentation, documentation for registration purposes as well as preparation and the making of batch documentation and SOP’s. I have prepared and made different kind of freeze drying course materials and also held and been teaching at both internal and external seminars and work shops designed for people from different levels in the organization (process operators, production and support chemists and engineers, QA and RA personnel etc.).

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