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Precision processes made easy The product is filled by means of eight rotary piston pumps, with ultra-precise dosage a defining feature of the system. For the filling volume of 1.8 ml, the maximum possible error is no more than ±0.5 per cent. The vials are sealed with a notched rubber stopper. The stopper is only inserted about half-way to allow for the downstream freeze-drying process. The vials can then be transferred directly to the freeze-dryer.
One Zydus Cadila operator per shift is responsible for overseeing the Macofar VF 18 aseptic liquid filler. This compact machine is installed in a cleanroom with laminar flow air conditioning. With a footprint of only three sq mt, it is extremely compact and inexpensive to maintain. “The Macofar technology is optimally integrated in our cleanroom environment. Also, it is very easy to retool and operate – and in pharmaceutical production that is a crucial advantage,”says Purohit
Strict safety and hygiene regulations intended to protect both the product and its consumers are applied when processing sterile parenterals. The concentration of particles and microorganisms has to be kept to an absolute minimum during filling and stoppering. The cGMP compliant design of the Macofar machines fulfills these requirements in a number of respects. A selective laminar flow prevents turbulent air movements in the vicinity of the open vials. The clean design of the machine additionally hinders particle formation in the critical zones.
Vial Filling with Good Service Included
When complex technologies are introduced, reliable service is a must. Onsite customer support begins when a new machine is installed and commissioned. Special technical training is recommended for all operators, and there is also maintenance and repair work to be done from time to time. Income Marketing Pvt Ltd, Mumbai is Romaco’s representative in India. It maintains close contacts with local users of Romaco technology.
Praising Income’s services Purohit said, “Their trusty service was a key factor in our decision to award the contract to Romaco Macofar.” He further added, “Machine downtime and other disruptions cost a lot of money. Thanks to the successful cooperation with Income and Romaco, however, that is something we never need to worry about.”
Aseptic Filling
How Automation Helps to Enhance Aseptic Filling Processes
* The author is Sales Director at Romaco
(ID:43105194)