“It is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing or manufacturing of medicinal products”
It is based on few principles that are listed below:
|(B) Selecting worst case Product: Solubility of API in water or other solvent used for equipment cleaning is a critical factor for ease of cleaning.
If two or more products emerge as worst case, the product with lowest therapeutic dose become worst case.
|Solubility||Approx Volume of Solvent in mm/gm of solute|
|Very Soluble||Less than 1 part (< 1)|
|Freely Soluble||From 1 to 10 part (1:10)|
|Soluble||From 10 to 30 part (10:30)|
|Sparingly Soluble||From 30 to 100 part (30:100)|
|Slightly Soluble||From 100 to 1000 part (100:1000)|
|Very Slightly Soluble||From 1000 to 10,000 part (1000: 10,000)|
|Practically Insoluble||More than 10,000 part (> 10,000)|
- Maximum Allowable Carry Over ( MACO):
(i) 10 PPM Criteria:
Sampling Procedure: After cleaning sampling of equipment is necessary to ensure previous batch residue is not carry to next batch/ product.
In this after cleaning first the visual inspection of equipment is done. If the surface of equipment is hard to inspect, a mirror should be used to check cleanliness of equipment.
|2. Swab sampling for microbial analysis:|
|a) Wear sterile hand gloves & mask to avoid microbial contamination.|
|b) Sterile cotton swab shall be used for swabbing soaked in sterile saline solution.|
|c) Collect the microbial swab before chemical swab.|
|d) Swabbing process is same as of chemical swabbing.|
|e) Send swab sample to QC microbiology lab for testing.|
- Rinse water sampling:
After visual inspection rinse the equipment with water quantity mention in protocol
Collect the rinse water in clean bottle and label them
Send the bottles to QC lab for analysis
- Visual inspection of Cleaned Equipments: Cleaned equipments shall be visually inspected first to check that no traces of previous product adhere to it. It is done by viewing the equipment from not more than 10 feet distance at 30° angle & in 200 lux light.
Dirty Equipment Hold Time (DEHT): The time from end of manufacturing till the beginning of cleaning process of equipment.
Hold time study of dirty equipment shall be carried out by keeping equipment idle for a period of 24 hours in dirty condition.
Clean Equipment Hold Time (CEHT): The time from end of equipment cleaning till use of equipment.
Hold time study of clean equipments shall be carried after completion of B type cleaning & by keeping equipment in idle condition in clean environment for 72 hours.
(NOEL) No observed effect level: It is the amount of drug that does not have any effect on human health.
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