Mini White Paper: Changeover on a Syntegon 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 to prepare the entire filling line for new production (new product, format size parts, different filling volume, etc.).

This topic becomes more and more relevant, especially for isolator systems due to accessibility and flexibility.

  • Syntegon’s goal is to reduce the changeover time by optimizing machines. This also depends on defined procedures at the drug manufacturer site to handle the changeover (Risk analyses and cleaning studies to be done, PQ, media fills, SOPs needs to be written, …)
  • Highly sophisticated lines can often be running in at least 2 shifts, 5 – 7 days a week. Sometimes a line needs to be prepared multiple times a week for different products and the efficiency of changeover time is crucial.

This requires different activities between the end of a production batch and the start of a new one.
(*Please see these examples that do not claim to be complete or in preferred order)

  • Stop active Batch
    • Monitoring equipment removal
    • Cleaning procedures (e.g. CIP), WashDown with detergents & WFI (e.g. toxic products) or manual wipe down by using IPA and / or WFI etc..
    • Removal of filling equipment, format parts, additional cleaning etc.
    • Setting up the filler for new batch, format parts, filling equipment, etc.
    • Glove tests (at least manual inspection, full testing mostly done only once a month)
    • Preparing barrier systems for new batch, biodecontamination cycle
    • Installing filling equipment, (eventually SIP), etc.
    • Prepare monitoring equipment, bulk loading Setup (washer, tunnel), SCADA, IPC batch, weight setup
  • Start new batch

The line preparation is mostly performed by two people and can take a few hours up to two shifts, depending on line configuration, drug specifics, cleaning procedures, room preparations and other custom factors.

*These examples shows different steps and required times for a standard filling line. These can vary depending on SOPs and on how fast people perform different steps to ensure the correct handling.

Biodecontamination cycle-time of an isolator is a small portion of overall changeover actions.
It depends on the size of isolator(s), loading condition, texture and types of surfaces and arrangements of different stations on filling machine under the influence of laminar air flow. It´s to guarantee an efficient surface penetration, especially on gloves, transport system, checkweigher for IPC, filling and closing station, viable and non-viable monitoring system, … by using the appropriate sterilant.

Matching the solutions enables effective isolator cycle times.
> Let´s consider biodecontamination cycle-time and different principles more closely.

VHP, HPV, iHP, aerosolized peroxide, … are some of the terms that you might come in contact with and the question is, which principle leads to the fastest and most effective 6-log reduction by having excellent surface penetration in an isolator system by guaranteeing highest process and production reliability.

Vaporized Hydrogen Peroxide (VHP)
Syntegon biodecontamination cycles are intensively tested under worst-case conditions at a fully loaded isolator with resistant BIs (D-value) and a realistically prepared filling machine.

After a VHP biodecontamination cycle comes the evacuation of peroxide. An appropriate air balancing in aeration mode and / or usage of catalytic converter reduces cycle times down to 1 hour or less for a production size isolator.

From design of filling machines and isolators to a fully qualified solution. Syntegon, formerly Bosch Packaging Technology, as a total portfolio supplier combines all elements to reduce the changeover time to a minimum.

About the Author: Jürgen Metzger is Barrier Systems & Process Specialist at Syntegon

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