Laundry in the pharmaceutical industry - solutions
In order to comply with the new GMP pharmaceutical equipment renovation, some pharmaceutical companies need to upgrade their factories, and the laundry room, as part of the pharmaceutical production enterprise, is also within the scope of renovation.
According to GMP standards, the clean areas required for the production of sterile drugs can be divided into four levels, from high to low: A, B, C, and D. The clean areas required for the production of sterile drugs can be divided into the following four levels:
Level A: High risk operation areas, such as filling areas, areas where rubber stoppers and open packaging containers are placed in direct contact with sterile formulations, and areas where sterile assembly or connection operations are carried out, should be maintained in a unidirectional flow operating platform (cover) to maintain the environmental state of the area. The unidirectional flow system must have uniform air supply in its working area, with a wind speed of 0.36-0.54m/s (guidance value). It should have a unidirectional flow state and be verified.
In closed isolation operators or glove boxes, lower wind speeds can be used.
Level B: Refers to the background area of the A-level clean area for high-risk operations such as sterile preparation and filling.
C-level and D-level: refer to clean areas with lower importance of operational steps in the production process of sterile drugs.
The grade of sterile drugs must meet the usage requirements of the area, which is also known as laundry equipment or clean laundry equipment.
Many electronic factories also require the use of laundry equipment or clean laundry equipment.
Laundry Equipment/Clean Workshop Laundry Equipment Configuration Plan
Eg:
Thick work clothes
1、 Basic information of electronics or pharmaceuticals
(1) Work clothes per shift: 2000 sets
(2) Laundry working system: one shift, working 10 hours per day
2、 Calculation of electronic or pharmaceutical laundry volume
(1) Work clothes (thick work clothes): 1.0 KG/set × 2000 sets=2000KG
Total:
Daily laundry volume: 2000 kilograms
Daily and hourly washing capacity: 2000KG ÷ 10 hours=200KG/hour
Thin work clothes
1、 Basic information of electronics or pharmaceuticals
(1) Work clothes per shift: 2000 sets
(2) Laundry working system: one shift, working 10 hours per day
2、 Calculation of electronic or pharmaceutical laundry volume
(1) Work clothes (thin work clothes): 0.5 KG/set × 2000 sets=1000KG
Total:
Daily laundry volume: 1000 kilograms
Daily and hourly washing capacity: 1000KG ÷ 10 hours=100KG/hour
Equipment required: hygiene, cleaning, washing, and drying integrated machine, isolation type double leaf hygiene washing machine, fully enclosed clean washing machine, and fully enclosed clean drying machine.