Posts Tagged ‘Isolation Technology’

Mini White Paper: Changeover on a Bosch Packaging Isolator Line

What is “Changeover Time”

ISPE Definition:
The time by which a processing area is cleared of supplies and components used in the manufacture of a previous product and then readied for production of a new product. This often includes parts change over and / or special cleaning to eliminate cross-contamination.

In other words:
Activities and the time needed between two batches …more




Article in Pharmaceutical Processing by Bosch’s Jürgen Metzger: The Fine Art Of Transferring Products Into Barrier Systems

Pharmaceutical manufacturing processes are becoming more complex and guidelines stricter. Accordingly, the focus in aseptic operations is of course protecting the aseptic interior of a barrier system against the environment and vice versa also protecting operators from highly potent pharmaceuticals. This requires suitable barrier technologies. One of the first steps is the categorization of the actual pharmaceutical product, followed by …more



Bosch Packaging Technology Chief Pharma Expert Dr. Johannes Rauschnabel blogs about containment and supplier partnership for PACK EXPO Healthcare Hub

Isolator

Bosch Packaging Technology Chief Pharma Expert Dr. Johannes Rauschnabel recently wrote a piece for PACK EXPO’s Healthcare Hub. The article discusses new developments in biological agents, barrier systems, and the changing role of equipment manufacturers.

Click here to read the article. …more


Video: 40 second, one-handed peristaltic tubing installation in a Bosch isolated FLT 1000

While today’s aseptic filling applications increasingly require the protection of both the product and personnel with elaborate air handling systems, automated decontamination processes, and the latest safety features, the growing need for specialized medicines produced in small batches means that efficient manufacturing systems also need to be flexible and have short changeover times. The Bosch FLT 1000 vial filler with Isolator offering is designed to meet precisely these needs. Case in point: without opening the isolator, its single-use peristaltic pump tubing can be exchanged, one-handed, in less than a minute. …more



Mini White Paper: The Ongoing RABS vs. Isolator Question

Isolator

by Christian Lavarreda

Over fifteen years have now passed since the Isolation Technology Task Force of the Parenteral Drug Association (PDA) published the influential Technical Report No. 34 (TR 34), “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products,” yet considerable confusion still surrounds the terms barrier, Restricted Access Barrier System (RABS), and isolator and their respective suitability and favorability in pharmaceutical fill-finish operations. …more



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