Standard Operating Procedure for Dispensing of solvent and liquid
1. Purpose
To provide a standard operating procedure for dispensing of solvent and liquid material in the warehouse.
2. Scope
The scope of this SOP is applicable for dispensing of solvent and liquid material in the warehouse at [company name].
3. Responsibility
Warehouse person: Dispensing of solvent and liquid materials
Warehouse supervisor: To verify dispensed material details, to record the activities in the batch manufacturing record
Manufacturing supervisor: To verify dispensed material details against the standard quantity mentioned in batch manufacturing record, to ensure calculation correctness
QA Person: To accord line clearance
Warehouse Head: To monitor the procedure compliance
4. Definitions
Not applicable
5. Procedure
5.1. Manufacturing person shall initiate a material requisition note for the required product. The requisition will contain details of material name, material code, batch number, and required date.
5.2 Warehouse person shall receive the material requisition note and plan for the material dispensing activity as per material requisition.
5.3 Bill Of Material (BOM) with Raw Material details (A.R. Number) for the batch to be dispensed shall be provided to the warehouse by the manufacturing department.
5.4 Material management software shall generate the formulation order where material details shall get arranged automatically based on FEFO (First Expiry First Out) followed by FIFO (First In First Out).
5.5 Only approved material will get populated in the list.
5.6 At a time, single batch material shall be dispensed. An open container of the materials shall be used first for dispensing.
5.7 Ensure that all required solvents or liquid materials are in the approved state before dispensing and no material is due for a retest.
5.8 Approved solvents or liquid containers shall be kept ready (through material movement route) after wiping the containers with a lint-free duster. Ensure that no leakage of solvent in solvent storage area at the time of entering into the room. Material shall be kept on the spill control pallet with adequate segregation.
5.9 Warehouse and Manufacturing personnel shall enter into the solvent dispensing area from the man movement change room.
5.10 Warehouse person shall ensure that area is cleaned for dispensing activity before the start of the activity. Accessories used for the dispensing is available with clean status label and instruments such as weighing balance are calibrated.
5.11 Use required Personal protective equipment (PPE) such as hand gloves, nose mask, Earmuff, Earplug, Goggle while working in dispensing area.
5.12 Switched “ON” the Fuming Hood and allow the area to stabilize for 5 minutes.
5.13 Ensure that Fuming Hood is working as intended.
5.14 Ensure that the temperature, relative humidity, and differential pressure are within the acceptable range.
5.15 Before starting the dispensing activity, line clearance should be done to ensure that area is cleaned, no previous product documents, and the residue is available in the area. Line clearance checks for dispensing shall be done by the user department, followed by the QA department. Line clearance shall be recorded in the batch manufacturing record.
5.16 The dispensing activity shall be carried out under the supervision of personnel from the warehouse and manufacturing department.
5.17 Clean container shall be brought into Solvent dispensing booth / fuming hood and place it on the balance to record the tare weight.
5.18 Adequate earthing to be provided by using crocodile clip during dispensing to the solvent container, weighing balance and container in which the dispensed solvent to be stored.
5.19 During dispensing, details to be verified on the material label, such as Description of the material, Item code number, A.R. Number, Retest date, and expiry date.
5.20 Material shall be weighed as per the quantities defined in BOM using the weighing balance. Ensure that the correct capacity of the weighing balance is used.
5.21 Material shall be dispensed in the pressure vessel designed to store solvents. Solvent dedicated pump shall be used for solvent transfer. Attach the crocodile clip to solvent drum. The lid of solvent drum shall be open slowly to avoid the suddenly flow of fumes.
5.22 The solvent transfer pump shall be placed into solvent container. Compressed air operated pump shall be used to transfer the solvent from main container to the container in which the material is to be dispensed. Adjust the flow of compressed air to transfer the solvent as per requirement.
5.23 Warehouse supervisor shall verify the standard quantity mentioned in the batch manufacturing record to ensure that the correct amount of material is dispensed. Adjust the quantity of solvent as needed as per the BOM.
5.24 The dispensed material shall be labeled with details such as product name, batch number, material name, item code, A.R. Number, Lot No., and container No.
5.25 Manufacturing supervisor shall verify the quantity dispensed against the standard amount, material code, A.R. number, gross weight, tare weight, net weight, and other details on the dispensed material label and verify the correctness concerning the batch manufacturing record.
5.26 Close the lid of solvent drum and the SS container in which material is dispensed
5.27 “Cleaned” status labels of containers shall be retained at the time of dispensing of raw material and attached with the batch manufacturing record.
5.28 Ensure that the dispensed container wheels shall be cleaned before transferring from dispensing area to the manufacturing room.
5.29 Different lots’ solvent shall be issued in separate containers.
5.30 After completing dispensing, the remaining material container shall be transferred to the warehouse through the material airlock.
5.31 Used Utensils and accessories shall be labeled with the status label as “Unclean”.
5.32 At the end of dispensing, if any material physical quantity found different from material management software stock, it should be adjusted in the system up to the allowable amount. If the difference is more than the defined acceptable range, it shall be investigated.
5.33. Before starting of next batch, cleaning of area and fuming hood shall be performed.
5.34. Cleaning process shall be documented in the area and equipment logbook.
5.35 After completion of dispensing activity, personnel working in the area shall remove the hand gloves and cut them to prevent re-use of it. Discard the gloves in the waste bin.
5.36 Any spillage of material while handling shall be handled using respective ingredient Material Safety Data Sheet (MSDS).
5.37 Spill control kit with absorbent pad shall be used for any accidental spillage of material.
6. Frequency
Every batch manufacturing where solvent is part of the BOM
7. Formats
Format for Logbook of solvents and liquids dispensing (Following are the content of logbook)
Date
Product Name
Batch No.
Batch Size
Material Code
Dispensing Start time
A.R. No.
Quantity dispensed
Dispensing End time
Dispensed by
Dispensing checked by
Cleaned by Cleaning checked by
