8 Comments

  1. Zeljko Joksimovic says:

    According to EMA Decision tree new revision, cycle must be above 121oC for at least 15 minutes, so it is not ok to set 121oC+/-1oC
    For calculation of Fo in product, temperature above 110oC (not 100oC) should be taken in account (same EMA document)

    1. You are absolutely right my dear friend. If you read the article carefully, it is step by step demonstration of the recipe parameters which can be set according to the bandwidth of those parameters.

      So, in the end, the authorized person who knows recipe setup will create and manage the recipe in compliance with the related regulations.

  2. Can you please write article on TS cycle development based on bioburden?

    1. Thanks, Rajendar having had a great time with Pharma GxP. The TS cycle development is already in the pipeline but delayed due to some other priorities. I urge you to Subscribe to the newsletter so you never miss an update!

  3. Surja Dharma says:

    On average, how long will it take for the whole cycle of the Recipe (heating till cooling) if I used 10 minutes as sterilization holding time at 121°C?

    1. Hi Surja, actually it depends on many factors like:
      – Pure steam quality
      – Other recipe set points
      – Piping clusters
      – System architecture etc.
      Due to these dynamics, it’s practically not possible to ideate. I also doubt why you sterilize for 10 minutes at 121°C.

  4. Vishal Adgaokar says:

    Please share Autoclave validation and Autoclave load pattern validation

    1. Thanks Vishal! It’ll be added as a fresh article soon. Stay tuned 🙂

Leave a Reply

Your email address will not be published. Required fields are marked *