To describe a standard operating procedure (SOP) for cleaning of reactors / equipments whenever being changed from one product to other product
1.0 PURPOSE:
To describe a standard operating procedure (SOP) for cleaning of reactors / equipments whenever being changed from one product to other product.
2.0 SCOPE:
The SOP describes in detail the method for cleaning of reactors / equipments whenever being changed from one product to other product.
3.0 RESPONSIBILITY:
The responsibility of cleaning of reactors / equipments whenever being changed from one product to other product as per the SOP lies with the staff of the rank not lower than operator of production department.
The responsibility of preparing, reviewing and approving the SOP lies with the Officer/Executive (Production), Head of Production and Head of QAD respectively.
4.0 METHOD:
4.1 [CHANGING OVER FROM ONE PRODUCT TO THE OTHER PRODUCT]
4.1.1 Open the manhole cover and bottom valve.
4.1.2 Clean the inner surface of the reactor by splashing with 50 L. water.
4.1.3 Drain the water washes and close the bottom valve.
4.1.4 Give a requisition to maintenance department to remove / disconnect the following accessories.
a) Any process lines connected to the reactors, all equipment and assembly (accessories) associated with the product.
b) Manhole cover
c) Bottom valve
d) Vapour line and reflux line
e) Charging line
f) Sampling line
g) Dummies
h) Receiver
4.1.5 Above accessories clean with soft water and followed by suitable solvent as mentioned in reactor / equipment cleaning SOP.
4.1.6 Give a requisition to maintenance department to refix the accessories of step 4.1.4.
4.1.7 Charge 10 L. methanol and close the manhole cover.
4.1.8 Heat the solvent of the reactor / equipment to reflux and maintain for 30 min.
4.1.9 While reflux open the receiver valve, collect the sample and combined to main sample of reactor / equipment cleaning.
4.1.10 If sample is rejected by QCD repeat steps 4.1.4 to 4.1.9.
4.1.11 After getting the clearance from QCD, check the reactor for any leaks by applying vacuum or pressure (whichever is applicable) and rectify if any.
4.1.12 Further clean the reactor / equipment as per the reactor / equipment cleaning (SOP) procedure.
4.1.13 The total time taken for carrying out steps 4.1.1 to 4.1.11 is about 3 hours.
4.2 FREQUENCY:
4.2.1 Cleaning operation will be done for any one product to another product.
5.0 RECORDING:
The cleaning operation shall be recorded by the staff of the rank not lower than operator of production department in the equipment cleaning record attached to the batch manufacturing sheet and register for equipment cleaning and use log.
Production, reactors equipments,
