Page Contents
1. Purpose
To lay down a procedure for cleaning, equipment line clearance & Operation of the Automated optical inspection machine.
2. Scope
It is applicable for cleaning, equipment line clearance & Operation of the Automated optical inspection machine.
3. Responsibility
Automated optical inspection machine Operator,
Production Officer
Production manager
Quality assurance officer
4. Cleaning Procedure of Automated optical inspection machine
Cleaning Materials/Cleaning Agents: Purified Water, Detergents, IPA
Cleaning Tools: Dry cloth lint-free.
For Product to Product Change Over and Batch to Batch Change Over
4.1 Remove the Previous product label from the optical checking machine.
4.2 Clean the inside surface with a lint-free cloth or wet mop with detergent if any kind of spoilage is observed. 4.3 Clean externally with a clean dry cloth.
Cleaning Schedule
The equipment should be cleaned before and after every product-to-product and batch-to-batch changeover. As per the above-given method.
Status label
Display the “Cleaned and Ready for Use” status label after cleaning the machine.
5. Automated optical inspection Line Clearance
5.1 Ensure that the area is cleaned as per SOP.
5.2 Ensure that the optical checking machine is cleaned as per the above-mentioned method. 5.3 Ensure that all trays, documents, and labels of previous products/batches are removed and the status board is updated.
5.4 Ensure that the optical checking area is free from the previous product.
5.5 Check the Temperature, Relative Humidity, and Differential Pressure of the optical checking room and enter the same in the Batch Manufacturing Record.
5.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which are to be recorded in the Batch Manufacturing Record (BMR).
5.7 After checking all the above points and the BMR, Final Line Clearance should be given by the In-Process Quality Assurance Officer.
6. Operating Procedure of Automated optical inspection machine
6.1. Check and make sure that Line clearance is duly checked and signed by QA Personal. 6.2. Transfer the filled vials into the s/s tray with proper labeling and give for individual checking.
6.3.Keep the vials in an inverted position to check for sealing, black particles under the whiteboard and Glass pieces, white pieces & fiber particles under the blackboard by shaking the Vials two to three times.
6.4. If necessary clean the vials with a wet cloth.
6.5. Segregate and put the good and rejected Vials in the respective tray.
6.6. Put green label for good Vials.
6.7.Put red label for rejected vials.
6.8. Collect and send 10 to 20 Nos of good Vials for In-process checking.
7. Precautions
7.1 Before the optical checking process, ensure that the optical checking machine is cleaned as per the standard procedure.
7.2 During the optical checking process attach the status label to the optical checking machine specifying the name of the product, Batch no, Mfg Date., and Expiry Date along with the signature of the production manager.