(a division of Watson-Marlow
Pumps Group), working with isolator specialist Extract Technology, has provided
an innovative liquid filling and capping solution that is tailored to the
operating requirements of MSD Animal Health (MSDAH).
Located in Milton Keynes, MSDAH is a global,
research-driven company that develops and manufactures a broad range of
veterinary medicines and services. Recently, the company wanted to add
additional capacity for processing bacteria/starting materials for the
production of animal health vaccines as the 350-employee site was using clean
rooms that were causing capacity constraint. As an existing user of
Watson-Marlow products, MSDAH saw an opportunity to improve the production
methods for these important pharmaceuticals.
"The main issue was to keep the vial filling process
sterile and isolated," explains the company's Production Support Manager, Kevin
Richardson.
Providing a solution required Watson-Marlow to work in
close liaison with Extract Technology, a dedicated manufacturer of isolator
units. Focussing on a Flexicon PD12P peristaltic dispensing pump at the centre
of the system, a customised flange was engineered to keep the pump drive and
control panel outside of the isolator, with only the pumphead sited within the
isolator unit.
Both the bacterial seed culture and the excipient (an
inactive substance that serves as the vehicle or medium for the drug) are manufactured
elsewhere and transferred into the isolator, where they are mixed together and
dispensed by the peristaltic pump into small capacity vials held in stainless
steel trays. The trays of vials are partially stoppered and placed in the
freeze drier. Once this process is complete, the vials are removed and capped
before being transferred out of the isolator.
The Flexicon PD12P peristaltic dispensing pump is proving
particularly popular for process engineers in the pharmaceutical, diagnostic
and biopharm sectors. Its peristaltic filling action means that the product is
only in contact with the sterile tubing and the filling nozzle. As a result,
there is no possibility for cross-contamination ensuring that no cleaning
validation is required. Furthermore, the unit is designed for easy product
changeover and offers high suitability for low volume production.
With a filling range from 0.1 to 250ml, the unit provides
virtually pulse-free flows with accuracy of ±0.5%. Absolute control is
guaranteed to the last drop, where aqueous products can be controlled either by
reversing, filling speed or acceleration to offer drip-free operation.
All other system equipment sits beneath the isolator,
equating to a significant saving in space, increased efficiency and a more cost
effective solution for the customer. The Flexicon filling and capping equipment
is built into the isolator in such a way as to be controllable, accessible and
easy to maintain.
Watson-Marlow also worked with Extract Technology to
engineer the control panel for the pump (based on a Flexicon MC12P master
control unit). A foot switch allows the machine operator to stop and start the
pump while his or her hands and arms are involved in processes within the
isolator. The MC12P controller is connected to a printer for recording
production/quality data.
A Flexicon FS10 semi-automatic tabletop cap crimping
machine has also been supplied and this is used to seal the vials at rates up
to 1000 units per hour if required.
"One of the key things for MSDAH was the integration
aspect and the ability of two suppliers to work in close partnership," says
Philip King, Sales Manager for Flexicon products. "It was essential that
Extract Technology had all the necessary information available to them and were
able to work co-operatively from a technical point of view with ourselves, and
vice versa. Having worked with Extract Technology previously, we were well
placed to meet this need."
Flexicon Liquid Filling offers a range of products from
stand-alone units for manual filling, through semi-automatic systems, to fully
automatic filling, stoppering and capping machines. The fully automatic systems
are customised to fit any glass vial, plastic bottle, test tube, eye-dropper,
or non-self standing micro-tube. All machines are designed to operate within
sterile environments.
For further information visit
www.wmpg.co.uk