Small Vial Filling How to Fill Vials the Easy Way
Zydus Cadila, a leading Indian pharmaceutical company, bought Macofar technology when it intended to expand production. The machine not only efficiently fills small vials but is also complaint to cGMP regulations. Read on to know more about it.
At the end of 2011, Zydus Cadila decided to increase its production capacities for pharmaceutical liquids by investing in new equipment. “We were looking for a high-speed machine at very short notice to fill parenteral products and help us cope with the rapidly expanding demand for our injectable preparations,” recalls General Manager Projects and Engineering, Zydus Cadila, Gaurang Purohit.
In order to meet these challenges, the company trusted Romaco’s Macofar VF 18 aseptic liquid filler. “We are very happy with the quality and value for money offered by Romaco’s Macofar technology,” Purohit notes. The additional advantage was that he machine was shipped within six months of the order being placed and installed at the company’s headquarters in Ahmedabad in May 2012. It has been operating in three shifts ever since, filling sterile injectables into vials.
The machine achieves a maximum filling speed of 18,000 vials an hour. The sterile products currently manufactured by the liquid filler are freeze-dried immediately after filling. This method is particularly common in the pharmaceutical industry because many APIs are more stable and have a longer shelf life after freeze-drying. The lyophilisate is dissolved in sterile water prior to administration and then injected directly into the body.
Why Filling Freeze–Dried Products is a Complex Challenge
Pharmaceutical liquids destined for freeze-drying are first filled into DIN/ISOcompliant, 4R tubular glass vials in liquid form. Vials with a height of 68 mm, for instance, are just 16 mm in diameter. In this case, the filling volume is as little as 1.8 ml per vial. The reason for this low fill level is the downstream lyophilisation process, during which the product expands. Filling these tall, slim vials at high speed is technically a complex process. Vials have to be optimally stabilized for processing on the automatic line.
Here the benefit of the Romaco Macofar VF 18 is that an infeed screw and starwheel separate the vials on their way to the dosing and stoppering stations. Thanks to the efficient transport system, these instable containers are guided safely to the various stations participating in the aseptic filling process. Several servo systems control the transfer, filling and stoppering steps. Hence, the risk of the thin-walled glass containers toppling over or breaking is ruled out.