VALIDATION PIC: NAJIHA

Validation Stage : Performance Qualification (PQ)

Validation Line : 68
Validation Date : 7/12/2022
Choice : 20
Size : M size & N/A size
Product : NB-AB-OLPF-035-SE-OBLU-ASTM
Latex : NANTEX 6729 + 7PHR HSD
Validation Reason : New product at Line 64

Target Setting : Normal Chain Speed vs Normal Main Oven Temp.

Chain Speed Range : 43.0 – 49.0k (average)
Main Oven Range : 110-130C

Production
Setting 1 Time Task
A1 2pm - 3pm 1. Record data for line speed, main oven temp., coagulant temp., and latex temp., for every 5 minutes during validation time.
B1 4pm - 5pm 2. Take chlorine sample every half hour and send to lab starting 2pm
C1 6pm - 7pm 3. GL to send the Process Control Checklist and validation form to QAI after complete by 7/13/2022

Packing
Setting Batch Start Time Task
1. Hold glove for all validation batches
A1 2pm 2. Prepare samples for each batch: - 1 inner M size & N/A size and send to lab
B1 4pm - 12pcs M size and send to lab
C1 6pm - 50 pcs M size and send to QAI
- 60pcs M size and send to PSI
*Samples should be taken 45 mins after batch start time.
3. Key in the details for the validation batch into the 'Quarantine Validation Batch' label
4. Before quarantine sticker is printed, please email the 'quarantine form' with details of green column to validation team
5. Paste the 'Quarantine Validation Batch' label onto validation batches pallet before sending to warehouse.
6. Validation team will verify the sticker pasted with packing PIC one day after validation. (Based on the details sent by packing)
7. Validation batch must not be included in sampling carton.
8. If validation batches are included, sampling carton must be quarantined at a designated area in warehouse and must not be
inspected until emailed PASS

Lab
Setting Batch Start Time Task
1. Conduct calibration for main oven at: 1.45pm
A1 2pm 4.30pm
B1 4pm 7pm
C1 6pm 2. Conduct testing on %CN and TSC for all 3 batches
3. Conduct hotbox testing for all 3 batches
4. Conduct powder test 2 times
(1st test: As normal, 2nd test: After 4 days from the first test)
5. Immediately send the extra samples to PSI. Write in the validation log book once the sample has been taken for powder test.
6. Conduct colour test for each batch.

QAI
Setting Batch Start Time Task
1. Provide BQR for all 3 batches with serial no that match the sample provided by packing
A1 2pm 2. Measure the dimension of gloves (3 batches) provided by packing
B1 4pm 3. Enter dimension data into public folder
C1 6pm 4. Please inform immediately if any of the 3 batches are not SP
5. Please send the dimension and BQR including with validation form and checklist from GL production to validation team
6. Retain dimension sample and repeat visual test after 4 days from validation date 7/16/2022

PSI
Setting Batch Start Time Task
1. Please conduct before aging and after aging for ASTM, EN for all 3 batches
A1 2pm 2. Before aging result must be provided to validation team latest 4 days after validation conducted: 7/16/2022
B1 4pm
C1 6pm