Aseptic Processing: A Review of Current Industry Practice

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-10-02-2004
Volume 28
Issue 10

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

External Link - article-128398.pdf

Articles in this issue
A Novel Freeze Pelletization Technique for Preparing Matix Pellets
Aseptic Processing: A Review of Current Industry Practice
Can Inserts Be Improved?
Analysis of a Kneading Process to Evaluate Drug Substance-Cyclodextrin Complexation
Drug Development Linked More Closely to Diagnostics
Preparation and In Vitro Characterization of Self-Nanoemulsified Drug Delivery Systems of Coenzyme Q10 Using Chiral Essential Oil Components
In The Spotlight-October 2004
October 2004
Visible-Residue Limit for Cleaning Validation and its Potential Application in Pharmaceutical Research Facility
The High Price of Success
Pharma Company Investment in Parenteral Manufacturing Capacity Picking Up
USP General Notices and General Test Chapters: Interpretations and Misinterpretations
Breaking the Barrier: Advances in Transdermal Technology
Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Bone structure 3d illustration, normal and with osteoporosis | Image Credit: © adimas - stock.adobe.com

Theramex Treatment for Osteoporosis in Postmenopausal Women Accepted by Scottish Medicines Consortium

Patrick Lavery
July 7th 2025
Article

The company estimated that more than 1000 women in Scotland at very high risk of fracture would be eligible for treatment.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Susan Haigney
July 2nd 2025
Article

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

Sterile capsules for injection. Bottles on the bottling line of the pharmaceutical plant. Machine after checking sterile liquids. Interferon, nasoferon. | Image Credit: © neznamov1984 - stock.adobe.com

ten23 health Joins Gerresheimer, SCHOTT, Stevanato Group in ‘Alliance for RTU’

Patrick Lavery
July 1st 2025
Article

The partnership was formed in September 2024 in response to increasing demand for aseptic filling technologies and processes.