NEWSLETTER
ISSUE
Apr to Jun, 2019 Volume 8
WirelessGT – Success Story in India
SKAN AG launched the WirelessGT, a fully automated glove integrity testing device, in 2013. Since then it is successfully used for isolators and RABs in the pharmaceutical industry. Globally, SKAN has supplied more than 1500 WirelessGTs, of which approximately 80% are sold for SKAN isolators and rest for isolators/RABs of other manufacturers. Pharmalab team, here in India, successfully supplied more than 160 nos. of WirelessGT to various satisfied customers in the pharmaceutical industry. Interestingly, out of 160+ nos. supplied in India, 80% were used successfully for other make Isolator/RABs and rest for SKAN make. This trend was different and contrary to the global statistics of SKAN WirelessGT.
Pharmaceutical companies in India that exports to the US and EU must comply with the stringent norms set by the regulators. To comply, companies upgrade their facilities by using modern technologies. As a result, today, an upward trend is seen in use of Isolators/RABs in pharmaceutical industry. Isolator/RABS being an important part of manufacturing facility, it necessitates regular attention and routine maintenance of critical components. One of the critical components is a Glove.
Gloves are regarded as one of the main potential sources of contamination. They are the weakest link to observe while maintaining the integrity of an Isolator. Therefore, regular glove integrity testing is of prime importance. Routine glove integrity testing is mandatory as per many regulations. The FDA Sterile Drug Products produced by Aseptic processing Guide indicates that “a faulty glove or sleeve (gauntlet) assembly represent a route of contamination and a critical breach of isolator integrity. With any use of gloves should be visually evaluated for any macroscopic physical defect. Physical integrity test should be performed routinely. The monitoring and maintenance program should identify and eliminate any glove lacking integrity.”
SKAN WirelessGT offers several unique features like reliable & reproducible results, ease of operation & maintenance etc. These simplifies the testing activity of gloves and makes the overall procedure efficient. Considering, the advantages of WirelessGT, customers were keen to use it for the Isolators/RABs supplied by other manufacturers. For the use of WirelessGT on isolators/RABs manufactured by others, Pharmalab-SKAN team provided a customised solution. To ensure proper fitment of test disc into glove port, a detailed drawing of the glove ports was prepared. Based on the drawings, customised design of WirelessGT was developed by SKAN. These customised WirelessGTs were then supplied, installed and successfully qualified at customer site by Pharmalab engineers. Today, we have developed the capability to supply a quality glove port on customer’s request to help them overcome the problems of leakage from a glove port on RABs/Isolator of other manufacturer. We have successfully carried out installation and commissioning for various projects of customised leak testing arrangement at customer sites giving them an extensive solution to their problem.This was made possible due to Pharmalab’s ability to provide on-site support, competent design engineering facility, calibration & qualification capabilities and well-maintained spare parts stock in addition to SKAN’s capabilityto provide customized solution.
Recently, in 2019, Pharmalab developed an audit trail software compatible to SKAN OPC server offering audit trail facility along with glove integrity test report to fulfil customer’s demand.
Pharmalab and SKAN as a team have taken extra efforts and have gone the extra mile to provide customised solution to the Indian customer with an aim to keep our commitment to customer satisfaction. We aim to maintain the confidence of our customers on our ability to provide a complete solution in glove management not just by supplying equipment but helping our customer from understanding the glove testing process and up to providing service for customized glove testing requirement.
