SOP Title: Operation and Cleaning of Leak Test Apparatus
- Objective:
To define procedure for Operation, Cleaning and Calibration of Leak Test Apparatus.
- Scope:
This SOP is applicable to the Leak Test Apparatus used to check sealing integrity of packed product in Packing Section of the Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for Operation, Cleaning and Calibration of Leak Test Apparatus.
- Engineering Department: To carry out Preventive Maintenance and Calibration and Maintenance as per procedure defined.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head – Production / Head – Quality Assurance.
- Procedure:
- Definitions :
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Officer, Executive of Engineering Department or any personnel trained to perform duties as per this SOP.
- Breakdown: Any activity leading to operation of instrument other than the set parameters and/ or unusual sound or vibration observed in the instrument.
- Calibration: Tests performed to ensure that the instrument is functioning as per set parameters. These tests are performed as per predefined frequency and also after any major repair or replacement of parts.
5.1.5 Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
5.1.5.1 Remove the previous batch residue.
5.1.5.2 During end of the shift.
5.1.5.3 Before starting the next batch of the same product.
5.1.5.4 Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
5.1.6 Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
5.1.7 Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Procedure:
| Safety Precautions/Instructions: | ||
| 5.2.1 | Check for any leakage of vacuum from desiccators by lifting the lid. If leakage is there, lid will come out. | |
| 5.2.2 | Leak test checked Tablet/ Capsules should not be added in batch ,even if it is in dry condition. | |
| 5.2.3 | Put the perforated plate on the blister before starting the test. | |
| 5.3 | Operation : | |
| 5.3.1 | Equipment Description: | |
| 5.3.1.1 | The testing assembly consists of the following parts:
1. Vacuum desiccators half- filled with water. 2. Vacuum pump fitted with dial vacuum gauge. 3. Rubber tubing connecting the desiccators to pump. |
|
| 5.3.2 | Sampling: Sample quantity to be taken for leak test should be number of blisters / strips sealed in one complete round of sealing roller plus one pack for single and plus two packs for double track machine. | |
| 5.3.3 | Testing Procedure: | |
| 5.3.3.1 | Collect the required number of strips/blister from the machine as mentioned on respective product BPR. | |
| 5.3.3.2 | Ensure that the desiccators is filled with two third of water. | |
| 5.3.3.3 | Add 2-3 drops of indigo carmine colour in water of the desiccators for clear observation. | |
| 5.3.3.4 | Immerse the strips/blister in the desiccators and cover it with the lid. | |
| 5.3.3.5 | Connect the lid with the vacuum pump through the rubber tubing. | |
| 5.3.3.6 | Close the stop-cork to maintain the vacuum inside the desiccators. | |
| 5.3.3.7 | Switch “ON” the vacuum pump, observe pressure on vacuum gauge till 380-400 mm of Hg of vacuum obtained. | |
| 5.3.3.8 | After achieving the vacuum up to 380-400 mm of Hg, hold the vacuum for 120 seconds for blister (PVC/Aluminium foil) and Aluminium/Aluminium foil. For glassine foil hold the vacuum for 30 seconds. | |
| 5.3.3.9 | Then release the vacuum by opening the stop cork and open the dedicator lid. | |
| 5.3.3.10 | Remove the blister/strips and wipe it externally with dry duster. | |
| 5.3.3.11 | De-blister or open the strip and examine the contents carefully. | |
| 5.3.3.12 | The number of Capsules or Tablets which have becomes sticky or moist should be counted and calculated as percentage of total number tested. | |
| 5.3.3.13 | After completion of batch, label the Leak Test apparatus as “ TO BE Type A Cleaned “ .. | |
| 5.3.3.14 | Record the activity in “Equipment Log Book” as per Annexure. | |
| Frequency:
1. Initially at the start of the blister/strip packing/sealing and for every two hour during the packing run or as mentioned in product BPR. 2. Every restart of the machine and after every break. 3. If any product run less than two hour then perform leak test at the start , middle and end of the packing. |
||
| 5.4 | Type A Cleaning: | |
| 5.4.1 | Switch “OFF” the main supply, dry clean the pump, rubber tube, pressure gauge, desiccators with the help of dry clean duster. | |
| 5.4.2 | Disconnect the rubber tube from desiccators and transfer the desiccators to the wash area. | |
| 5.4.3 | Drain the water from the desiccators and clean the desiccators, plate and lid with 0.1 % teepol (soap) solution. | |
| 5.4.4 | Wash the cleaned parts with 5-7 litres of potable water to remove the traces of soap solution. | |
| 5.4.5 | Clean the leak test apparatus vacuum pump, rubber tube with moist clean duster followed by dry clean duster. | |
| 5.4.6 | Ensure the cleanliness visually for absence of product residue and affix “Type A Cleaned “label to the Leak Test Apparatus. | |
| 5.4.7 | Record the activity in “Equipment Log Book” as per Annexure. | |
| 5.5 | Breakdown | |
| 5.5.1 | If breakdown occurs during operation, hold the batch in closed condition. Inform to the Head Production. | |
| 5.5.2 | If break down occurs during operation ,after completion of repair repeat the test with fresh blister /strips/container. | |
| 5.5.3 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.5.4 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.5.5 | If breakdown occurs prior to start of operation, follow step 5.5.2 | |
| 5.5.6 | Record the breakdown activity in Equipment Log Book. | |
| 5.5.7 | After completion of repair, the operations can be resumed. If required, perform Type A cleaning. | |
| 5.5.8 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.5.9 | Record the repair completion activity in Equipment Log Book. | |
| 5.6 | Preventive Maintenance: | |
| 5.6.1 | Perform the Preventive Maintenance as per Annexure. | |
| 5.6.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.7 | Calibration: | |
| 5.7.1 | Calibrate the vacuum gauge for vacuum holding capacity , by approved external party once in a year.
Range: 0- 760 mm of Hg. |
|
| 5.7.2 | Affix the “Calibration Status Label” on the Apparatus as per SOP. | |
| 5.7.3 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
- Abbreviations:
| Abbreviation | Expansion |
| PVC | Poly Vinyl Chloride |
| % | Percent |
| BPR | Batch Packing Record |
| E | Equipment |
| mm | Milli Metre |
| Hg | Mercury |
*Note – Ready to use SOP available in “DOWNLOAD” Section.