Sunil Nirmale, GM, ACG Engineering, in his technical topic, ‘High-speed integrated packaging line with 21 CFIR/EBMR’, highlighted the needs of pharma packaging sector. He also highlighted different aspects such as the need for a high speed blister machine; fully integrated packaging lines; reduction in packaging cost; latest technology at competitive price; prompt and reliable service and support etc.
Speaking on Blister X + Karton X, a product from ACG, he expounded on its salient
features. He informed that the product has robotic transfer system and other suitable transfer systems to deal with high capacity and fast production. The product also has a single HMI for the complete line, and offers easy and quick access through tabs/phone as an option.
He further explained the features of a high speed cartoning machine and the ways
to make a high speed blister machine.
Nirmale also touched on another important requirement of a high speed machine, and the 21 CFR PART 11 (title 21 of Food and Drugs, CFR-Code of Federal Regulations and part 11-electronic records; electronic signatures). He said, “The intended objective of part 11 is batch manufacturing records, standard operating procedure, method of analysis, deviation and change control and stability studies, qualification of equipment, instrument and water system and process validation has been maintained by the company on paper in order to comply with FDA’s cGMP.”
The benefit to the user of the product is speed, audit ability and accountability; data
guarantee; traceability; online history; authenticity, data integrity, confidentiality of records; ease of keeping records, paperless with automation; fast information search with advanced searching capabilities; reduces the cost of record keeping, storage space; built in system for authentic report and signatures.