1.0.
OBJECTIVE
:
1.1
To lay down procedure for the Cleaning of cone blender.
2.0.
SCOPE :
2.1 This procedure is
applicable for the
Cleaning of cone blender at any pharmaceutical industry.
3.0.
RESPONSIBILITY:
3.1
Operator shall be responsible for cleaning
of cone blender.
3.2
Production Officer shall be responsible for
verification of cone blender.
4.0.
ACCOUNTABILITY
:
4.1
Head of the department
5.0.
PROCEDURE :
5.1.
FULL CLEANING
(TYPE-B CLEANING)
5.1.1. Turn
Off the electrical supply &Remove “To be Cleaned” tag from equipment.
5.1.2. Remove
the residual loose powder from the exterior & interior surfaces of the
equipment with the aid of fresh dry lint free cloth or with vacuum cleaner.
5.1.3. Clean
the equipment with purified water. Remove adhered sticky materials by using
nylon scrubber. Use 0.5% SLS solution
(If required). Scrub manually for about 2 mins. and then rinse with purified
water for about 2 mins. and shall be dried by using compressed air for about 5
mins.
5.1.4. Cleaning
of machine body – clean with purified water and scrub with soft nylon brush.
Rinse and thoroughly clean with purified water.
5.1.5. Finally
mop the entire equipment with 70 % IPA solution.
5.1.6. The
production officer shall check equipment for cleanliness and affix ‘Cleaned’
label on equipment with filling all details in Label. Record the cleaning
activity in operation and Cleaning log of equipment.
5.2.
LIMITED
CLEANING (TYPE-A CLEANING)
5.2.1. Remove
the residual loose powder from the exterior& interior surface of the
equipment with the aid of fresh dry lint free cloth or with vacuum cleaner.
5.2.2. Clean
the floor by using vacuum cleaner.
5.2.3. Collected
powder of vacuum cleaner shall be packed in plastic bag and send to scrap yard
for further disposition.
5.2.4. The
production officer shall check equipment for cleanliness and affix ‘Cleaned’
label on equipment with filling all details in Label. Record the cleaning
activity in operation and Cleaning log of equipment.
5.3.
CLEANING
CRITERIA
FOR LIMITED CLEANING
5.3.1. For batch change over (maximum up to 10 consecutive
batches of same product or 5 days, whichever is earlier)
5.3.2. Change
over from lower strength to higher strength of the same product having same
colour.
5.3.3. If fully cleaned equipment is not used within the
prescribed time. (i.e. maximum 2 days after full cleaning).
FOR FULL CLEANING
5.3.4. For product change over
5.3.5. After 10 consecutive batches of same product or 5
days, whichever is earlier.
5.3.6. If limited cleaning is not carried out within 24 hrs
of equipment last use.
5.3.7. If equipment is not used within 48 hrs of limited
cleaning.
5.3.8. After preventive maintenance.
5.3.9. Changeover from one strength to another of the same
product with different colour.
Change
over from higher strength to lower strength of the same product.