Clean room question

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

What is the difference between Class A,B,C,and D cleanrooms?

I have worked in 2 different clean rooms one was in the pharmaceutical industry where I was involved in the dispensing of raw materials.

I wore a suit specifically for the clean room where I was all covered up sometimes I wore a tyvek suit, gloves taped,safety glasses and beard mask and white clean room shoes.It was a finished pharma plant.What kind of clean room was this?

I also worked in the medical device industry making stents and the gowning was not as stringent. I wore mop cap safety glasses and beard mask if applicable and a white coat and shoe covers.what kind of clean room was this?

2

Hi!
Please, have a look to the annex 1 of this link:

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm

Here is explained the differences between grades.

3

Hi Dear,

Clean room A,B,C & D are different classes as defined in the Europian Guide to Good Manufacturing Practices which was revised in 2003.

According to this revision note , cleanrooms are defined in four Grades A,B,C & D on the concept of Maximum permitted number of particles/ m3 of 0.5 micron size at rest and in operation(these are air borne Particles).

Grade A&B - permitts 3500/m3
Grade C - 350,000/m3
Grade D - 3,500,000/m3

Grade A&b is correpond to Class100 (FS 209D),Class M3.5 ( FS 209E) & ISO 5
Grade C is correpond to Class10,000 (FS 209D),Class M5.5 ( FS 209E)& ISO 7
Grade D is correpond to Class100,000 (FS 209D),Class M6.5 ( FS 209E)& ISO 8

Regarding different mode of gowning as followed by you at different organisations, it is only to controll the generation particles and human safty.

Because not only particles are generated during process, human body may be the source of particles like hair falls, shreding of scales from skin.

All guidelines we are following, tells us that we should maintain cleanroom, but not a single guidelines explain how to maintain these cleanrooms.We have prepare our guideline to maintain the system ( which is called SOP, Standard Operating Procedure). All these gowing procedures we are following, are explained in the SOP.

Gowing procedure are designed based on the type of area we are working.As clean the area we have to follow that much more closed gowning procedure. For example two types of gowning procedure followed in pharmaceutical industries in two different area : Dispening Area/Raw Mterial Sampling Area /Core Manufacturing Area and QC Lab/Packing Area. In first working area we are following secondary gowning and in second we are following Primary Gowning procedure.

Gowning procedure differs from organization to organizaion.

With best fo Regards
Bijay K Mohalik