This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
News|Articles|February 2, 2019
- Pharmaceutical Technology-02-02-2019
- Volume 43
- Issue 2
Sterile Boot Covers
Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.
Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.
The boot covers are made of 100% polypropylene breathable spunbond-meltblown-spunbond fabric and have Clean-Don ties for enhanced protection and a secure fit. A two-inch vinyl edge allows for an improved moisture barrier.
The CE-certified boots are made without natural rubber latex, silicone, or BHT preservatives and are triple-bagged and vacuum-packaged. Each individually bagged pair of boot covers has a visual sterilization indicator to show that it has undergone gamma sterilization. Available sizes include small/medium, large/extra-large, and universal.
Articles in this issue
over 7 years ago
Spectroscopy Facilitates Lean Analysisover 7 years ago
Fundamentals of GMP Warehouse Designover 7 years ago
Effective Root Cause Determinationover 7 years ago
Process Development Best Practices for Topical Drug Productsover 7 years ago
FDA Promotes Quality Standards to Reduce Shortagesover 7 years ago
Small-Batch Aseptic Fill/Finish Systemover 7 years ago
Automatic Desiccant Inserterover 7 years ago
Multi-Shaft Mixer and Disperserover 7 years ago
Innovations Maintain the Cold Chainover 7 years ago
Advances in Engineering of Protein-Based APIsRelated to this article
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
Swedish biotech companies have a broad and varied product pipeline that is attracting attention from venture capitalists and pharmaceutical companies.
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Weekly Basal Insulin Efsitora: A New Biologics CMC Benchmark
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EU Clears AstraZeneca's Trixeo for Asthma, Opening New Manufacturing Demand for Single-Inhaler Triple Therapy
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The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
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