SOP Title: Operation and Cleaning Calibration of Tray Dryer
- Objective:
To define a procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Tray Dryer.
- Scope:
This SOP is applicable to Tray Dryer, used for the drying of granules/raw material and cleaned accessories, installed at the Production area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Tray Dryer.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the Swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
- Engineering Department: To perform the preventive maintenance and calibration of Tray Dryer, wherever applicable.
- Quality Control Department: To analyse and report the swab/rinse samples.
- Accountability:
Head, Production Department, Head, Engineering Department and Head Quality Assurance
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance department or any personnel trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or operator of engineering department trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases
- Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part or change in colour.
- Monthly, if it is not in used after cleaning.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine
- 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.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Switch ‘OFF’ the main supply during cleaning, loading and unloading of material in to the Tray Dryer. | |
| 5.2.2 | Use proper personal protective equipment like nose Masks, Gloves, while handling the material. | |
| 5.2.3 | Do not over fill the material in to the trays to avoid the spillage of material. | |
| 5.2.4 | During drying, flap of the inlet air should be open as per requirement. | |
| 5.2.5 | Set temperature controller as per requirement of material to be dried or as mentioned in product BMR. | |
| 5.2.6 | Switch OFF the heater while drying the material/ accessories/ product which contains IPA | |
| 5.2.7 | Ensure that, after attaining set temperature heater should be cut “OFF”. | |
| 5.2.8 | Ensure the validity of Calibration and Preventive Maintenance before starting any operations. | |
| 5.3 | Operation of Tray Dryer | |
| 5.3.1 | Visually check and ensure that, Tray Dryer is cleaned and line clearance is taken as per line clearance checklist on specific product BMR. | |
| 5.3.2 | Remove “Cleaned” status label and affix “In-process” label to the tray dryer. | |
| 5.3.3 | Ensure that Tray Dryer main is switched “OFF”. Then open the Tray Dryer door by pulling the handle provided on the door. | |
| 5.3.4 | Remove the tray one by one from the dryer and load the required quantity of material to be dried in the trays. Spread the material evenly for uniform drying. | |
| 5.3.5 | Insert the material filled trays in the tray cabinet in proper sequence and close the door of the Tray Dryer. | |
| 5.3.6 | Switch “ON” the main electric switch then switch ON the toggle switch. Push the green colour button to switch “ON” the blower. | |
| 5.3.7 | Set the required temperature by rotating the temperature controller Knob | |
| 5.3.8 | Rotate the temperature controller knob clockwise to increase the temperature and rotate it in anti-clockwise to decrease the temperature. The set value will be displayed. | |
| 5.3.9 | After attaining the set temperature, heater wills automatically cut-off, to maintain the set temperature inside the tray dryer. | |
| 5.3.10 | In-between rack (mix) the material and check for proper drying. | |
| 5.3.11 | Dry the material till the LOD is Attained as per the respective BMR / as per the material requirement | |
| 5.3.12 | Dry the machine accessories or parts till it get dried completely without any water traces. | |
| 5.3.13 | After drying unload the material from the tray one by one in to the cleaned container lined with double poly bag. | |
| 5.3.14 | Affix dully filled status label to the container in which, the material is unloaded. | |
| 5.3.15 | Record the total drying time in the product BMR. | |
| 5.3.16 | Record the usage time in equipment log book as per attached Annexure. | |
| 5.3.17 | After completion of drying activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.4 | Type A Cleaning (Batch to Batch Cleaning) | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.4.2 | Remove all previous batch documents, containers and labels from the area. | |
| 5.4.3 | Clean the trays with the help of clean dry duster. | |
| 5.4.4 | Dry clean the drier grooves /cabinet, inner surface and outer surface of the dryer with the help of vacuum cleaner /dry clean duster. | |
| 5.4.5 | Ensure the cleanliness and affix “Type A CLEANED” label as per SOP. | |
| 5.4.6 | Record the cleaning time in equipment log book as per Annexure. | |
| 5.5 | TYPE B Cleaning (Product to Product Cleaning) | |
| 5.5.1 | Switch “OFF” the main switch, and then remove the trays one by one from the tray compartment. | |
| 5.5.2 | Remove in process status label and affix “To be Type B cleaned” status label. | |
| 5.5.3 | Remove all labels, containers and documents of previous product. | |
| 5.5.4 | Keep the trays on trolley and transfer to the wash area for cleaning by covering with poly bag with “To Be Type B Cleaned label. | |
| 5.5.5 | Cleaning of trays: Clean the trays first with potable water to remove the adhered powder then apply 0.1 % soap (teepol) solution then wash with sufficient quantity of potable water. Finally rinse with purified water. | |
| 5.5.6 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples of the trays. | |
| 5.5.7 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.5. | |
| 5.5.8 | Cleaning of External Surfaces of the tray dryer: Clean the outer surface of the tray dryer, exhaust flap, using moist duster then wipe with clean dry lint free duster. | |
| 5.5.9 | Cleaning of Chamber: Clean the chamber with Vacuum Cleaner followed by moist duster. | |
| 5.5.10 | Drying of trays: Wipe all trays with a clean dry lint free duster then put the trays in tray cabinet in reverse position. | |
| 5.5.11 | Switch “ON” the tray dryer for drying. After drying of trays switch “off” the tray dryer followed by main switch. | |
| 5.5.12 | Record the activity in equipment log book. Refer Annexure. | |
| 5.5.13 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, switch “OFF” the main supply and inform to Head Production and QA Associate. | |
| 5.6.2 | Record the drying time in the product BMR. | |
| 5.6.3 | Fill the “Complaint note” and submit to engineering department. | |
| 5.6.4 | Fill the “Incident report “and submit to quality assurance department. | |
| 5.6.5 | Unload the product / material only if required and keep the product/ material in closed condition as per requirement. | |
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.6.3. | |
| 5.6.7 | Record breakdown activity in Equipment log book . | |
| 5.6.8
|
After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement. | |
| 5.7 | Preventive Maintenance: | |
| 5.7.1 | Perform the preventive maintenance as per Annexure. | |
| 5.7.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.7.3 | Attach the preventive maintenance label on the equipment. | |
| 5.8 | Calibration: | |
| 5.8.1 | Calibrate the temperature controller from external approved agency once in a year as per Annexure. | |
| 5.8.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached | |
| 5.8.3 | Attach the calibration label on the equipment. |
- Abbreviation:
| Abbreviation | Expansion |
| BMR | Batch Manufacturing Record |
| LOD | Loss On Drying |
| % | Percent |
| QAD | Quality assurance Department |
| IPA | Iso Propyl Alcohol |
| v/v | Volume by Volume |
| ml | Mili Litre |
CALIBRATION FOR TEMPERATURE CONTROLLER OF TRAY DRYER
OBSERVATIONS
| Sr. No | Standard Temperature (°C) | Observed Temperature on UUC (°C) | Deviation (± 2°C) |
| 1 | 25 | ||
| 2 | 50 | ||
| 3 | 100 | ||
| 4 | 150 | ||
| UUC : Unit under calibration | |||
| Remarks: The results comply / Not comply with the acceptance criteria | |||
*Note – Ready to use SOP available in “DOWNLOAD” Section.