SOP Title: Operation and Cleaning of Stainless Steel Trolley
- Objective:
To define procedure for Operation and Cleaning of Stainless Steel Trolley.
- Scope:
This SOP is applicable to Stainless Steel Trolley used for transferring of material, accessories and equipment in the production section.
- 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 of Stainless Steel Trolley.
- Engineering Department: To perform the preventive maintenance of Stainless Steel Trolley.
- Quality Assurance Department: To provide line clearance prior to operation. To approve the Preventive Maintenance reports. To review and approve the SOP and Annexure.
- 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.
- 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 / Vacuum in the following cases,
- Remove the previous batch residue.
- During end of the shift.
- 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.
- After seven days of cleaning before use, if trolley is not in used after cleaning.
- After replacement or repair of any product contact part.
- 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, quarterly and half
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Do not over load the trolley more than the 75 kilogram. | |
| 5.2.2 | Check that, trolley wheels are working properly by moving empty trolley on floor | |
| 5.2.3 | Check visually, trolley wheels are free from any threads / sticky material. | |
| 5.2.4 | Do not stand or sit on the trolley or do not use for personnel movement. | |
| 5.3 | Operation | |
| 5.3.1 | Before use ensure that, trolley is clean and smooth moment of wheels is free by checking backward and forward movement of the empty trolley. | |
| 5.3.2 | Take the trolley from the dedicated area and hold the trolley with handle provided on the upper part of the trolley. | |
| 5.3.3 | Keep the material / product to be transferred on the trolley within the capacity of the trolley. | |
| 5.3.4 | Push the trolley forward by holding the handle of the trolley. | |
| 5.3.5 | During passing from the door, one person should hold the door to open, and then pass from the door to the next area. | |
| 5.3.6 | After reaching the shifting/transferring place, lift the material from the trolley platform by hand and slowly keep in the required place. | |
| 5.3.7 | Clean the trolley with wheel by moist clean duster before transferring to one area to another area. | |
| 5.3.8 | After using keep the trolley in the dedicated place. | |
| 5.3.9 | After completion of activity, label the trolley as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.4 | Type A Cleaning | |
| 5.4.1 | Clean the platform, handle and base of the trolley by wiping with clean dry duster. | |
| 5.4.2 | Clean the trolley wheels with moist duster by tilting the trolley and rotating the wheels manually. | |
| 5.4.3 | Ensure the cleanliness of the trolley usually for absence of dust / powder | |
| 5.4.4 | Check the wheels for absence of any adhered sticky powder / treads and affix “Type A Cleaned’ label on the trolley. | |
| Frequency: During batch changeover and moving from one area to another area. | ||
| 5.5 | Type B Cleaning | |
| 5.5.1 | Clean the platform, handle, wheels and base of the trolley by wiping with clean dry duster. | |
| 5.5.2 | Wash the trolley platform, handle, wheels with 10-15 litres of potable water. | |
| 5.5.3 | Clean the trolley platform, base, handle with 0.1% soap (teepol) solution then wash with 10-15 litres of potable water to remove the traces of soap solution. | |
| 5.5.4 | Tilt the trolley and clean the wheels with 0.1 % soap (teepol) solution by rotating the wheels then wash with 5-7 litres of potable water. | |
| 5.5.5 | Keep the trolley on wet duster and move the trolley forward and back ward 4- 5 times to remove the any adhered material to the trolley wheels. | |
| 5.5.6 | Ensure the cleanliness by visually and dry the trolley with clean dry duster. | |
| 5.5.7 | After successful completion of cleaning process, label as “Type B Cleaned”. | |
| Frequency of cleaning: 1. During product change over 2. After any major maintenance to the trolley. | ||
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, hold the transferring activity and unload the material /container from the trolley. Inform to the Head Production. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.6.4 | Store the unloaded capsules in suitable SS closed container. | |
| 5.6.5 | If breakdown occurs prior to start of operation, follow step 5.6.2. | |
| 5.6.6 | After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning. | |
| 5.6.7 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 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. |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| PDD | Production Department |
| PKG | Packing |
| E | Equipment |
| TAB | Tablet |
| % | Percent |
| QAD | Quality Assurance Department |
| QA | Quality Assurance |
| v/v | Volume by Volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.