Standard Operating Procedure for handling of gas cylinders in Quality Control Laboratory
1.0 Purpose:
To describe the procedure for handling all types of gas cylinders.
2.0 Scope:
This procedure is applicable for all types of gas cylinders used in Quality Control Laboratory at [Company name].
3.0 Responsibility:
RA and above – QC: Procurement, usage, opening and closing of gas lines at user point.
Engineering Technicians: Connecting of gas cylinders and check the pressure.
Manager/Designee – QC: To ensure the activity to be performed as per procedure.
4.0 Definition:
Nil
5.0 Procedure:
5.1. General instructions:
5.1.1. All personnel working in areas where compressed gases are used or stored must receive instructions regarding the safe handling of gas cylinders, emergency and evacuation procedures, the use of appropriate personal protective equipment and steps that have to be taken in the event of a leak or fire in or nearby the work area. (Refer SOP-QC-SYS-081, current edition)
5.1.2. Nitrogen, Hydrogen, Oxygen (zero air), Helium and LPG gas cylinders are used in Quality Control Laboratory.
5.1.3. All gas cylinders have a unique color code for identification and it is displayed near the cylinders. (For e.g. Nitrogen-Grey, Hydrogen-Red, and Helium-brown etc.)
5.1.4. Do not remove any labels or other form of identification from any gas cylinder.
5.1.5. Never interchange regulators and hose lines among different types of gases.
5.2. Gas Cylinder Storage and Labeling:
5.2.1. When gas cylinder is received, following checks shall be conducted:
a. The contents are identified either by labels, color code.
b. Leak test
5.2.2. Gas cylinders shall be stored in a well-ventilated area. All gas cylinders must be stored in a secured upright position to a sturdy permanent structure to prevent the cylinder from falling or being knocked over.
5.2.3. Gas cylinders shall be stored in accordance with their physical and chemical properties. Refer material safety data sheets for specific instructions.
5.2.4. All gas cylinders shall be anchored individually.
5.2.5. All gas cylinders must have status label as – “Filled” or “Empty” (Refer Attachment – 1 and Attachment -2).
5.2.6. Empty and filled gas cylinders shall be kept separately.
5.2.7. Gas cylinders shall be considered “empty” if their pressure is less than 25 psi or 1.76 Kg/cm2.
5.2.8. Gas cylinders shall be kept in a continuous ventilated place.
5.2.9. Do not store gas cylinders near ventilating systems or other openings through which gas may spread to other parts of the building.
5.2.10. Do not store gas cylinders where there is a risk of dropping them or having heavy objects fall on them or where they may be struck by a vehicle.
5.3. Handling of Gas Cylinders:
5.3.1. Prior to connecting a cylinder, check the Color code of the Cylinder and check quality attributes on the CoA against the received cylinder [Note down the Serial number]. Prior to connecting a regulator, open the gas cylinder valve slightly and then immediately close it to blow out dirt or debris from the valve assembly. Aim the valve away from the operator and any other personnel present during this operation.
5.3.2. Always open the gas cylinder valve slowly. Never force the valve to open. If the valve cannot be opened by the wheel or small wrench provided, return the gas cylinder.
5.3.3. To shut down a system, close the gas cylinder valve and release the pressure from the entire system through a hose that is not being used. After connecting the cylinder, check for any leakages at the connectors using soap solution.
5.3.4. Always turn off gas cylinders from the main stem valve (not the regulator). Turn off any cylinder slowly.
5.3.5. Movement of the gas cylinders shall be done carefully. Hand trucks must be equipped with a clamp or chain to secure the gas cylinders in place or they must be specifically designed for container handling.
5.3.6. Never drag, roll, or slide a gas cylinder in an attempt to move it.
Note: Never drop gas cylinders; never allow gas cylinders to strike each other; and never strike gas cylinders with a metal instrument.
5.4. Receipt and Entry of Gas Cylinders:
5.4.1. After receipt of the Gas Cylinders, check the details like type of cylinder, grade, supplier etc.
5.4.2. Details of the Gas cylinders shall be recorded in the register as per the Attachment – 3 “Record for Receipt and Entry of Gas Cylinders”
5.4.3. Enter all relevant details i.e. receipt date, Challan no., Cylinder no., and Total no. of cylinders received in the Receipt and Entry of gas cylinder register.
5.4.4. While issuing a new filled cylinder for use, enter all relevant details i.e. issue date, Cylinder no. taken, Balance Quantity in the same register of Receipt and Entry of gas cylinder.
5.4.5. Once identification tests for Nitrogen gas are passed, Approved label ( as per format SOP-QC-SYS-098/F7) shall be affixed onto the Nitrogen cylinder.
5.5. Consumption of Gas Cylinders:
5.5.1. Enter all relevant details i.e. Cylinder name, Cylinder No. and Pressure in kg/cm2 as per Attachment – 4 “Record for Consumption of Gas Cylinders”.
5.5.2. Check the Gas cylinder pressure and record it daily before use.
5.5.3. Pressure check is to be carried out for Nitrogen, Helium, Hydrogen and Air cylinder.
5.5.4. Before initiating the consumption of Nitrogen cylinder for relevant activity such as for DSC, TOC, GC, during the sampling of hygroscopic material etc, Identification tests as per the European Pharmacopoeia (Identification B and C) shall be conducted.
5.5.5 Identification test conducted on each Nitrogen cylinder received shall be recorded in Attachment-5 (Record for performing test B as per European Pharmacopoeia on nitrogen gas) and Attachment-6 (Record for performing test C as per European Pharmacopoeia on nitrogen gas.)
6.0 Acceptance Criteria:
Not Applicable
7.0 Frequency:
As and when required during the quality control operations.
8.0 Format for recording:
8.1. Label for “Filled” Gas Cylinders
8.2. Label for “Empty” Gas Cylinders
8.3. Format for “Record for Receipt and Entry of Gas Cylinders”
Record for Receipt and Entry of Gas Cylinders
| Name of the Gas Cylinder : |
| Grade : |
| Supplier : |
Details of Receipt and Entry
| Date of Receipt | Challan No. | Received Cylinders Nos. | Total No. of Cylinders | Sign & Date | Date of Issue | Cylinder No. taken | Balance Quantity | Sign & Date |
8.4. Format for “Record for Consumption of Gas Cylinders”
Record for Consumption of Gas Cylinders
| Name of the Gas Cylinder : |
| Grade : |
| Supplier : |
Details of Consumption
| Date | Cylinder No. in use | Pressure observed (kg/cm2) | Sign & Date |
8.5. Format for “Record for performing test B as per European Pharmacopeia on nitrogen gas”
Record for performing test b as per ep on nitrogen gas
| Date of Nitrogen Cylinder Receipt | Cylinder Number | Date of Nitrogen Cylinder Sampling | Sampled & Tested By | Complies / Does not comply |
8.6. Format for “Record for performing test C as per European Pharmacopeia on nitrogen gas”
Record for performing test c as per ep on nitrogen gas
| Date of Nitrogen Cylinder Receipt | Cylinder Number | Date of Nitrogen Cylinder Sampling | Sampled & Tested By | Complies / Does not comply |
8.7. Format for “Approved label for Nitrogen gas cylinder”