Many active ingredients of oral solid dosage forms are highly active and
potent compounds that require special care during production to avoid exposure
of the operators to the drug. In recent years, the focus of operator protection
has shifted from cumbersome personal protection equipment (such as ‘moonsuits’)
to contained equipment to avoid contact between operator and product. The goal
is to allow the operators to work in shirt sleeves by introducing containment
measures in the production equipment that reduce the airborne exposure levels
of the product to safe levels.
GEA Pharma Systems nv – Collette™ - recommands the ULTIMAPRO™, Single
Pot Processor (One-Pot Processor), for contained granulation and drying of
highly potent compounds.
The concept of a Single Pot Processor in itself already ensures contained
processing by avoiding product transfers and executing the unit operations of
mixing, granulation and drying in one machine. Additionally, the ULTIMAPRO™ can
be equipped with several features to optimise the containment of toxic
products:
- Product feed and discharge valve can be equipped with Buck® high
containment split butterfly valves,
- and upon the request of the customer, even with isolator boxes.
- A sampling valve that allows the operator to take samples during the
process without having to stop the machine, open the bowl, or even open a port
in the lid, can be integrated into the processing chamber and adapted to
different containment levels.
- The sample container is completely contained allowing the sample to be
transported to the QC lab without exposure to the atmosphere.
The concept of containment not only applies to the production area. When
working with organic solvents, recovery and containment of these solvents is as
important as containment of the product itself. The ULTIMAPRO™ is equipped with
a very efficient recovery system that can recover more than 99% of the used
solvents.
Even for cleaning, the concept of containment is applied. The ULTIMAPRO™ can
be supplied with a wide range of washing-in-place and fully automated
cleaning-in-place options. CIP features include spray nozzles adapted for most
adequate cleaning of product feed, product filter, bowl, lid and discharge
valve (for example retractable spray nozzles for the lid). Even downstream
equipment such as a mill can be incorporated in the CIP system.
Single Pot technology can be tested in the Process Development Center
of GEA Pharma Systems nv – Collette™ in Wommelgem, Belgium ... Read more about Single Pot
Processing
Business Contact:
Wim Van der Goten
Sales
Director
GEA Pharma Systems nv - Collette™
BE-2160, Wommelgem,
Belgium
Office: +32 (0) 3 350 12 39 / Fax: +32 (0) 3 353 20 55,
Email:
wim.vandergoten@geagroup.com
Press Contact:
Kris De Baere
Marketing Manager
GEA
Pharma Systems
Office: +32 (0) 3 350 12 41, Mobile: + 32 (0) 473 73 19
45
Email: kris.debaere@geagroup.com