Air cleanliness grade for manufacturing non sterile liquid and semisolid products

Microbiology
1

Regarding Pharmaceutical Manufacturing Areas:

What is the air cleanliness grade which is sufficient for areas of preparation and filling of the following types of Non sterile products which are applied to skin or orally: syrups, suspensions, emulsions, ointments, gels & creams (Is it Grade D or what) ?

Is there any reference which specifies this issue ?

@Sajjad_Ahmad @Ankur

Thanks a lot

2

There is no requirement in air cleanliness grade for Non Sterile products, you can choose on what grade you will control depending on the risk assesment you conducted. we call all the rooms for non sterile as CONTROL NOT CLASSIFIED.

3

regarding of all this (orally: syrups, suspensions, emulsions, ointments, gels & creams) all this consider ISO 7 Grad C as Federal stander E209 or please reading the USP 1115 -1116

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@micro.ezz

USP Chapter 1115 only mentions that inhalation products are of higher risk than other non sterile products therefore it needs higher classification e.g. ISO Class 8

USP Chapter 1116 talks only about sterile products

I am asking about non sterile liquid and semi-solid products

5

WHO Technical Report Series, No. 961, 2011, Annex 5
PIC/S PE 010-4 Annex 2

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@cwever

WHO Technical Report Series, No. 961, 2011, Annex 5 is now obsolete after publishing WHO Annex 8 TRS 1010 (2018) and WHO Annex 2 TRS 1019 (2019) which do not specify a grade for non sterile production facilities

PIC/S PE 010-4 Annex 2 does not specify grade for non sterile production facilities

7

ISO 14644-1 should be used for classification of cleanliness

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8

I am saying that assigning a class to non sterile products needs to be clearly stated in guidelines as occurring with sterile products

9

ISO 14644-1 (2) should be used for classifi cation of cleanliness according to concentration of airborne particles (determination of number of sample locations, calculation of sample size and evaluation of classifi cation from the data obtained).

Please read ISO 14644-1 (2) it contain all data regarding non sterile classification

10

Is there a clear statements that non sterile pharmaceutical products are manufactured in a certain class in ISO 14644-1 ??

11

Maybe ISO14644 part 5 Operations