Product change over cleaning

Quality Assurance
1

stage to stage PCO cleaning is required?
Ex:- From stage-3 to stage-2 Equipment Product change over cleaning is required or not ?

2

Product change over of each equipment is required even during the campaign of same product after manufacturing of certain number of batches or after predefined duration of time within a campaign. This is governed by internal SOP or a protocol. This is also applicable for stage to stage PCO cleaning.

2 Likes
3

It’s mandatory…

4

Although it is not mandatory it is a part of GMP to assure product quality.

5

I agree with you Sir.

6

Thank you.

7

Hello,

Thank you for the answer. I meet a problem while preparing SOP for cleaning validation campaign length. In the cleaning validation, we are using worst-case approach. Suppose that the worst-case product is A (its score is the highest - 100). The second worst-case product is B with the score of 80. My problem is: in the cleaning validation campaign, what if we produce only 10 batches of A, and 20 batches of B, which product should be selected for the campaign?

Thank you for spending time reading my question.

8

For more details You have to see the PDA TR No.29.
Tq

9

Product-A only you should be selected

2 Likes
10

Thank you for the answer.

11

Dear Sir,

For campaign cleaning hold study:

  1. Is it required to take 0th hour sample before start of campaign batches?
  2. Is it required to collect microbial sample after reduced cleaning activity between batches?
  3. Is wet swab-Normal saline microbial swab can be used for sampling from equipment in between batches ?
  4. Is product residues need to collect between batches for MLT Test for information purposes?
  5. If campaign batches are not worst case product-Is it required to take chemical assessment sample after full cleaning process along with physical observation and microbial sample?

Thanks

12

  1. Is it required to take 0 th-hour sample before the start of campaign batches?
    Yes, it is necessary to have a baseline value (Microbiological determination). 0 th hour sampling should be done immediately after cleaning the equipment in case of clean equipment hold study after a campaign of the specific number of batches or specified period of manufacturing. Clean equipment hold time usually is in the range of 24 to 96 hours depending upon storage conditions of clean equipment and the background environment.

  2. Is it required to collect microbial samples after reduced cleaning activity between batches?
    It is not required for routine cleaning activities. (Necessary for cleaning validation). Once established then only as a part of verification / Re-validation we can take swab samples for microbiological determination.

  3. Is wet swab-Normal saline microbial swab can be used for sampling from equipment in between batches ?
    Yes, you can do that. However, it is not necessary for routine cleaning activities.

  4. Is product residues need to collect between batches for MLT Test for information purposes?
    You should do it as a part of the Re-validation of cleaning procedures.

  5. If campaign batches are not worst-case products it required to take chemical assessment samples after full cleaning process along with physical observation and microbial sample?
    Generally, this is followed as a part of cleaning verification may be on a weekly or fortnightly basis. Cleaning validation should be performed for all worse cases. This should include but not be limited to identification and evaluation of all worst-case:

    • Drugs with higher toxicities
    • Drugs with higher drug potencies
    • Drugs of lower solubility in their cleaning solvents
    • Drugs with characteristics that make them difficult to clean
    • Swabbing locations for areas that are most difficult to clean
    • Maximum hold times before cleaning
2 Likes
13

Thank you so much…

14

You are always welcome.