Product / Batch Change Over Procedure turn around time is the time between the production of the last good part of the current batch and the first good part of the new batch. In other words, this is the time it takes you to physically check the machine and manually record the Product / Batch Change Over Procedure on each machine. Important points are given in identifying this method. Justification, review, review and approval, communication, training, implementation, and Evaluation.

Product / Batch Change Over Procedure are an integral part of many manufacturing facilities. However, they also represent a loss of productivity. After all, when you’re converting batches, you’re not producing the product. This is further enhanced in pharmaceutical manufacturing facilities where Product / Batch Change Over Procedure and batch control processes are subject to regulations. So, how do you minimize product/batch changeovers? Let’s first explain what it is.

 

PURPOSE :

To lay down the procedure for change over in Manufacturing and Packing area.

SCOPE:

This SOP shall be applicable for the Batch to Batch and Product to Product change overs carried out for area and equipment in Manufacturing & Packing area at the Production department.

RESPONSIBILITY:

1. Execution: Section Supervisor.
2. Checking: Production Manager.
3. Head of the Production Department.

REFERENCES:

1. In-house.

PROCEDURE:

BATCH TO BATCH CHANGEOVERS:

1. Batch to batch changeover is the change over from one batch of a product to another batch (next batch) of the same product in granulation, drying, compression, coating & packing section.
2. For individual equipment, first ensure that the process of that batch on that particular equipment or area is complete, and the product is removed or has proceeded further for the next stage.
3. Remove the entire residual product like granules, fines, tablets, strips, etc. from the equipment and the area.
4. Remove the status label of the previous batch.
5. Clean the equipment with the dry clean lint free cloth, nylon brush and use vacuum as per the requirement.
6. Clean the accessory equipments like dust extractors and dehumidifiers in the area as per their respective SOP’s.
7. Affix the status label for the next batch. Get the area and the equipment certified by Q.A. person and record it on the batch document of the new batch to be processed.
8. Start the processing of the new batch.

PRODUCT TO PRODUCT CHANGEOVERS:

1. Product changeover is changeover of the area and the equipments after processing of one Product and before starting the processing and another product. This is essential to avoid the contamination of previous product into the new product to be processed in manufacturing and packing sections.

Status labeling for area & equipments:

1. Remove the product label/ in process label from the equipment and area.
2. Affix ‘To be cleaned’ Label to equipment and to the area.
3. Remove the previous processed product from the area for storage or further processing.
4. Remove the entire residual product like granules, fines, tablets, strips, etc. from the equipment and the area
5. Clean the equipments and the area as per their respective standard cleaning
   procedures.
6. Clean the return filters of AHU’s.
7. Raise the intimation for swab analysis to quality control department.
8. The Q.A. person shall take the swab of the equipments from the specified area as per the standard operating procedure, by using the specified solvents and swab samples should not be hold exceeding the hold time period.
9. The area cleanliness shall be certified by Q.A. person by visual inspection of the area.
10. The results of swab test shall be informed to production department by released sticker/slip. After receiving clearance form Q.A, affix ‘Cleaned’ status label to the area & equipment.
11. In case of compression machine if the machine is not used within one shift, apply thin layer of food grade oil to the turret to prevent rusting, and affixed “To be Cleaned” label. Before taking the machine for compression take the swab. The results of swab test shall be informed to production department by release slip/sticker.
12. After the receipt of the clearance from Q.A. assembly of the equipment can be started.
13. Affix the status label and start the operation.
14. Mentioned the status of the equipment/ process in the remarks column of Operational Log Book.

SHIFT AND CLEANING:

1. Before the end of the shift the machine is to be stopped & ensure the cleaning of the machine & accessories by wiping with dry lint free cloth.
2. Ensure cleaning of in process area & disinfectant solution poured in the respective drains.
3. All the in process containers will be properly closed & affixed with the Under Process Label mentioning the status.
4. The same should be entered in the Operational Log Book.

NOTE:

1. At the start of the shift ensure the cleaning of in process equipments, if the batch is continued for more than one shift.
2. If same product is continued for more than 3 days then cleaning of equipments & area as per respective SOP & take line clearance from Q.A. department.
3. Complete cleaning of the area & equipments after three batches (For Batch to Batch) & after every batch (For Product to Product). Take clearance of Q.A. department before work start.
4. Mentioned the type of cleaning as:

• Type A: Product to product change over.
• Type B: Batch to Batch changer over.
• Type C: Shift end cleaning.