Tablets & Capsules

TC0518

Issue link: https://www.e-digitaleditions.com/i/977310

Contents of this Issue

Navigation

Page 22 of 47

Tablets & Capsules May 2018 21 R The FDA has eased the way for pharmaceutical manufac- turers to automate processing lines with safe, fast, and adapt- able vacuum transfer equipment. This article discusses ways that vacuum systems can improve pharmaceutical manufactur- ing processes. ecent FDA regulations and guidances have simplified the notification procedure pharmaceutical companies must follow when making certain changes to equipment, technology, and processes. The agency now considers adopting material handling equipment such as a pneu- matic conveyor a level-one change, which the company may document in an annual report rather than in a time-consuming supplement. Several FDA documents indicate that automated mate- rial transfer is preferred over manual transfer for pharma- ceutical processes. Appendix A in the FDA's "CMC Postapproval Manufacturing Changes to be Documented in Annual Reports" states that a "decrease in the number of open handling steps or manual operation procedures" has "minimal potential to have an adverse effect on prod- uct quality." Similarly, "Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation" states that "change from non-automated or non-mechani- cal equipment to automated or mechanical equipment to move ingredients" is "unlikely to have any detectable impact on formulation quality and performance." As a result of this FDA guidance, pharmaceutical companies are increasingly incorporating vacuum trans- fer equipment into their manufacturing processes. Compared to manual transport and loading, a vacuum conveyor can reduce safety, sanitation, and environmen- tal hazards; increase processing-line speed; and stream- line production. To clarify how vacuum transfer equipment, which- operates in semi-continuous and continuous modes, fits Using vacuum transfer equipment to improve pharmaceutical processing Doan Pendleton Vac-U-Max pneumatic conveying

Articles in this issue

Archives of this issue

view archives of Tablets & Capsules - TC0518