In order to assist manufacturers in complying with the ISO 11607 standard requirements for packaging process development, equipment manufacturers are increasingly incorporating validation software and ...

Packaging for pharmaceutical products is aimed as to ensure that medicines arrive safely in the hands of the patients for whom they are prescribed. Manufacture of pharmaceutical products, quality ...

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel. Q. We are planning to market a new drug (film coated ...

Figure 1. (click to enlarge) Effect of temperature on seal strength. The green bars represent samples created using low temperature. The orange indicates packages created using the high-temperature ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

The authors outline a validation approach for the manufacture of a “legacy product,” taking into consideration recent guidelines. The aim is to demonstrate the validity and capacity of the ...

Cold-chain and thermal packaging lives or dies on proof. Customers expect food, pharmaceuticals and specialty chemicals to arrive within tight temperature bands, and regulators expect evidence that ...

Today's injection mold manufacturers are much more than 'just moldmakers.' As OEMs - particularly those in the medical and automotive industries - become more and more dependent upon their supply ...