1.0 OBJECTIVE & SCOPE
To maintain the equipment tidy and clean. To preventive cross contamination between products Review and approval.
This procedure is applicable for dismantling and cleaning of Insp. m/c Review, Approval.
2.0 RESPONSIBILITY
Doing : Operator
Checking : Chemist
3.0 ACCOUNTABILITY :
Head of the department
4.0 REASON FOR REVISION :
Routine review & Logo of company is changed.
5.0 PROCEDURE (Review, Approval)
5.1 Procedure for Cleaning :
5.1.1 Remove “TO BE CLEANED” tag from equipment.
5.1.2 Turn “OFF” the electric supply & remove the plug.
5.1.3 Dismantle the following part and take it to the washing area.
5.1.4 S.S. feed hopper
5.1.5 Capsule S.S. outlet
5.1.6 Wash the above parts using tap water (Use nylon brush if required to clean and to remove adhered sticky mass).
5.1.7 Finally Rinse it with D.M. Water & then With 70% I.P.A & allow to dry it and arrange in it on Inspection in reverse order of dismantling.
5.1.8 Clean `Material receiving and delivering assembly’ in the same sequences as above.
5.1.9 Remove the dust from inspection machine belt and cleaned the belt with lint free clothes dipped in D.M. water & then with 70 % I.P.A & allow it to dry.
5.1.10 Clean surrounding area of the machine as per respective SOP.
5.1.11 Record the details in equipment cleaning record as per annexure I of this production SOP.
5.1.12 Affix a “CLEANED” tag label on the machine.
5.1.13 FREQUENCY : Product to product change over for batch to batch cleaning.
5.1.14 SAFETY : Protected Motor from contact of purified water.
5.2 Procedure for Operation :
5.2.1 Clean the machine and surrounding area and set the according to the product which is being Inspection Machine.
5.2.2 Affix the stage label.
5.2.3 Take Line clearance from Q.A. Department as per respective SOP
5.2.4 Operate machine Slowly to ensure correct setting.
5.2.5 After setting, machine and collect the capsule from outlet.
5.2.6 Set the in process parameters according to product in process specification.
5.2.7 After setting the in process parameters give the intimation to Q.A. Department for checking the physical parameters of that product in production area.
5.2.8 After approval of Q.A. Dept. Load the Capsules in hopper fully, close the lid.
5.2.9 Ensure that the all parameters are correct.
5.2.10 Load the Capsules in to hopper using clean SS scoop
5.2.11 collect the Capsules in clean plastic container lined with double poly bag use the double poly bags in case of hygroscopic products.
5.2.12 Affix container label on each container in prescribed format.
5.2.13 Record the in-process parameters according to the frequency given in Batch Production Record and fill the Temperature and RH readings as per the frequency given in BPR.
5.2.14 Cover the Capsules container with lid and keep it on a pallets in production area.
5.2.15 Weigh the container on calibrated electronic platform balance and note it on to the container label and in the BPR.
5.2.16 Keep rejected Capsules in a separate container with proper identification as a recoverable reject Capsules.
5.2.17 Affix a “TO BE CLEANED” tag label on machine.
5.2.18 PRECAUTIONS :
5.2.19 Do not operate the machine in reverse direction.
5.2.20 Do not operate the machine without loading the Capsules into the hopper
5.2.21 Check the Cleanliness and proper oil-lubrication before starting the machine.
6.0 ABBREVIATIONS :
EFF. : Effective
SOP : Standard Operating Procedure
Mfg. : Manufacturing
DT. : Date