一． Entrance Control:

1． Clean safety shoes with shoe cover and helmet are required in the clean stage

2． All person shall not enter or exit from closed door or other location except designated air lock room.

3．Forbid entering with other worker badge.(200 RMB confiscate both badges

4．Entrance control for materials, machines, tools shall be assured，these materials is clean and without oil stain.

5．Bringing unapproved tools and materials.

6． Material entry or exit form special materials entrance.

7． Cleanroom gloves are required in the ultra clean stage area.

8． Clean working clothes are required in the ultra clean stage area.

二．Cleanroom Housekeeping

1．Trash dumpsters or containers must be used in fab by all.

2．Materials for the interior of the building will arrive on site individually packed. Dirty materials shall be unpacked outside the building in a designated area. The outer box will be removed and disposed of into trash containers.

3．Orderly storage of material at designated area has to be assured during all stages of construction.

4．Vacuum cleaners have to be used to remove dust/rubbish; Brooms are not allowed(Daily housekeeping).

5．Vacuum cleaners have to be used to remove dust all time when carrying out dust working, such drilling.

6.HEPA filter vacuum cleaners have to be used to doing housekeeping.

7．.All trash must be collected at any moment during work.

8．Tidy your work area after work done.

9．All trash and spent materials must be removed daily.

10.Tidy your storage area.

11.No smoking allowed in clean room.

12.No food or beverages allowed in clean room.

13.Forbid urinating or spitting.

三．Cleanroom Construction Requirement:

1.No work without permit or expired permit

2．Wipe down ladder before entering clean area, especially working platform.

3．Dirty platform must be removed form cleanroom.

4．Unpainted sprinkle pipe on raise floor in cleanroom.

5．Dirty work not allowed without approved isolation.

6．Temporary construction walls must be erected to isolate cleanroom from contamination generated during work.

7．Forbid to do any cutting in cleanroom.

8．Booth must erect for welding or hot work.

9．Gas cylinder should wrap with plastic sheet.

10．Placing and isolating wires and cable on height.

11．Keep the corridor clean and clear; do not obstruct the corridor.

12．Forbid opening any emergency door except emergency.

13.Prefabrication shall complete outside of the cleanroom when using welding or cutting.

四．Piping foothold

1．Only Scrubbed/general exhaust ducting and electrical cable tray are sufficient strength for foothold.

2．No step or pull PVC piping, plastic piping, hazardous chemical pipes, small stainless steel pipes, etc.

3．Do not step on FFU.

五．Protection for ground and wall

1．Scaffold wheels or any other wheels shall be wrapped with approved tape to protect ground.

2．Note booties on ladder feet. .

3．Noted new cleanroom taped to wheels if it was dirty.

4．Replaced a new cleanroom taped if it was lose or damaged.

5．Must lay floor protection vinyl sheet or plastic sheet below ladders or working platform.

6．Lay floor protection vinyl sheet or plastic sheet below materials.

7．Avoid oil stains on the floor due to the dirty work at cleanroom.

8．Do not lay any materials or tools next to cleanroom wall; Away cleanroom wall at least 1 meter.

9.Moving tools or materials must be off ground. 

The premises dedicated to the manufacture of medicinal products have to be monitored. Depending on the type of product to manufacture and whether it is a sterile or a non-sterile medicinal product, the requirements are more or less demanding. Besides, the amount of rules to be respected also increases the greater the risk of contamination for the product is. Consequently, most regulations and the most demanding requirements exist for the monitoring of rooms dedicated to the production of sterile medicinal products.

The substantial size for room/cleanroom monitoring is the particle concentration. It determines the cleanroom class which has to be first demonstrated in the qualification and reiterated in the context of re-requalification. Where and how particles in the critical zone A (= ISO class 4.8) have to be measured is directly laid down in Annex 1 of the EU GMP Guide.

With regard to the turbulent streamed rooms (B, C, D) that surround the sterile core A, Annex 1 requires the use of ISO 14644-1 (2015). By naming it in a mandatory GMP regulation, this ISO standard is also mandatory but only for sterile manufacturing. ISO 14644-1 (2015) contains a table listing the number of measuring points depending on the room size but only for the measurements concerning the qualification/re-qualification of the cleanroom determination with regard to particle concentration.

However, a risk-based approach should define the number and positions of the measuring points. Here, ISO 14644-2 applies. According to the technical interpretation of Annex 1 (PIC/S PI 032-2), permanent particle monitoring is required for zone A and indirectly for zone B too.

Microbiological monitoring is also described in a standard. But DIN EN ISO 14698 provides no details about the number of measuring points per area but requires a risk-based approach.

With regard to the manufacture of non-sterile forms, there are far fewer regulations. However, this greater degree of freedom often leads to uncertainties. Usually, one leans against the classification A-D and defines own zones such as D', E and F where each zone has an own and separated monitoring concept.