1.0 Purpose
1.1 To define a standard cleaning and operation procedure of Drum Blender.
2.0 Scope
2.1 This procedure is applicable for Drum Blender (60 kg) of tablet manufacturing area at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only concern operator is responsible for normal operation. He/ She inform the supervisor about any deviation from normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.
3.3 Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 BMR : Batch Manufacturing Record
5.0 Materials
and Equipment
5.1 Tap water
5.2 Hot water (60⁰ c)
5.3 Purified water
5.4 Hand brush
5.5 Clean lint free cloth
5.6 Detergent Solution / Cleaning agent: 0.4%
(w/v) Sodium Lauryl Sulphate solution; 4 gm Sodium
lauryl Sulphate is dissolved in 1.0 liter of portable / tap water to prepare
detergent solution.
5.7 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Use mask and hand gloves during operation.
6.2 Check the electric connection before operation.
6.3 The screw of the ring and ribbons of the drum blender should be tightened well.
6.4 Cover the electric switch board and motor with polybag during cleaning.
7.0 Procedure
7.1
Cleaning
7.1.1
After working, Switch
“OFF” the electric supply.
7.1.2
Empty Drum transfer to the equipment cleaning
area.
7.1.3
Remove the lid by loose
the bolt fitted outside the lid.
7.1.4
Wipe off residual
powder by dry lint free cloth.
7.1.5
Wash with Potable water
at least two times till all the residue is washed off.
7.1.6
Use Detergent Solution
/ cleaning agent & scrub the parts if required.
7.1.7
Finally rinse with
purified water.
7.1.8
Wipe off all the parts
with 70 % v/v solution of Isopropyl Alcohol (IPA) and allow drying.
7.1.9
Machine operator /
worker will request Production Officer and QA Officer for checking visual inspection.
7.1.10
At first Production
Officer will check the machine and its surroundings, then QA Officer will check
the machine and its surroundings. If it found satisfactory result, then he /
she will issue “Cleaned” label.
7.1.11
Record in Machine
logbook and affix the label of “Cleaned” in the machine.
7.1.12 After cleaning the
machine if it remains without operation for next 72 hour, will undergo
Re-cleaning operation.
7.2 Operation
7.2.1
Production person shall
ensure the cleanliness of the machine.
7.2.2 Before starting the
operation production person get the line clearance from QA person and affix the
status label with Product Name, batch
details to equipment.
7.2.3
Ensure that electric
supply is disconnected.
7.2.4
Open the lid cover of
drum mixer.
7.2.5
Load the materials as
per blending procedure mentioned in the BMR.
7.2.6
Put the lid over the
loading end and tighten it well with the help of wing nut.
7.2.7
Close the safety guards
so that limit switch is operational. Put “ON” the electric supply.
7.2.8
Set the timer for the required time period as
per Batch Manufacturing Record.
7.2.9
Rotate the blender for the specified time as
per the blending procedure.
7.2.10 When blending is over, switch “OFF” electric
supply and get the unloading end in proper position for unloading.
7.2.11
Unload the material by scooping in double poly
bag containers.
7.2.12
After unloading affix “To Be Cleaned” label
and fill the “Machine Logbook”. (Annexure-I)
8.0 Reference Document
8.1 In-house
9.0 Annexure
9.1 Annexure- I : Format of Machine Logbook
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head
of Production or his nominee give the training of operator and worker.
