CFS - GLFC / STANDARD OPERATING PROCEDURE
Maintenance and Operation of Water Purification Systems
SOP Number: M52506/024/001/
TITLE: Maintenance and Operation of Water Purification Systems
APPROVING OFFICIALS:
DD / MM / YY
Approved By:______Management___/___/___
Concurred By:______QAU Manager___/___/___
Prepared By:______/___/___
1.0Introduction
1.1Purpose
To assure the proper maintenance and operation of Corning brand water purification systems for general use.
1.2Scope
This general-use technical SOP is a management directive for all projects/studies of Natural Resources Canada, CFS-GLFC, which utilize Corning brand water purification systems for the conduct of GLP compliant studies.
1.3Definitions
Calibration– Actions taken to correlate readings or output to expected values for known standards.
Deionizer – An instrument that removes ionic material (such as salts) from water.
Distillation Unit – An instrument that boils and recondenses water.
Document Control Official (DCO) - The person specified by management who is responsible for controlling designated documents, including SOPs.
Effective Date - The date from which the procedures given in a SOP are to be implemented by CFS-GLFC. The effective date is a date specified by management or the date of distribution.
Good Laboratory Practices (GLPs) - Requirements set forth by the Organization for Economic Cooperation and Development (OECD) to assure the high quality and integrity of laboratory test data required to evaluate the health, environmental effects or fate of chemical substances and mixtures.
Logbook – A detailed chronicle of all maintenance, repair and/or calibration conducted on a specific instrument used in generation, analysis or sample measurement to produce raw data.
Maintenance– Routine actions taken on an instrument or piece of equipment to assure continuous performance according to accepted quality standards and specifications.
MSDS – Material Safety Data Sheet, a summary description of a chemical, reagent or substance prepared by the manufacturer or supplier and required by WHMIS legislation to inform workers about procedures required to safely work with the material.
NA - Not Applicable.
Quality Assurance Unit (QAU) - Persons designated by management to ascertain that the study is in compliance with the OECD Principles of Good Laboratory Practice (OECD GLP, 1998), and who are completely independent from the conduct of the study for which they are performing quality assurance functions.
Repair – Periodic replacement, change or renovation of parts of an instrument or piece of equipment to compensate for accidental breakage or wear and to assure good operating condition of the instrument or equipment.
Standard Operating Procedures (SOPs) - Management directives which describe all administrative or technical routine procedures conducted in a laboratory or field operation that are not covered by a chemical specific or study specific protocol.
Study Director - The individual responsible for the overall conduct of the non-clinical health and environmental safety study.
Study Plan – A document that defines the objectives and experimental design for the conduct of the study, and includes any amendments.
Test Facility Management – The individual who has the authority and formal responsibility for the organization and functioning of the test facility according to the Principles of Good Laboratory Practice (OECD GLP, 1998).
WHMIS - Workplace Hazardous Materials Information System, a national information delivery system used to inform employees about hazardous materials in the workplace.
1.4Safety
1.4.1 Persons using solvents or other hazardous materials must use minimum personal protective equipment as stipulated in the current version of SOP No. M52506/014, The Use of Personal Protective Equipment.
1.4.2 Persons using any solvents, chemicals, reagents or other hazardous materials must do so in accordance with the pertinent MSDS sheets and WHMIS labels which are stored on a shelf in the laboratory and in accordance with the current version of SOP No. M52506/015, The Safe Handling of Hazardous Materials.
1.4.3 All persons must receive WHMIS training and be familiar with emergency procedures as described in the CFS-GLFC Emergency and Fire Safety Manual, prior to working in a laboratory using hazardous materials. WHMIS and emergency procedure training as well as records associated therewith are to be coordinated by the CFS-GLFC safety officer.
1.5Materials
The critical materials required to operate and maintain water purification systems include:
1.5.1 Distillation unit (Corning MegaPure six litre auto model MP-6A).
1.5.2 Deionozer (Corning MegaPure model D2).
1.5.3 Automatic collection system (Corning ACS).
1.5.4 Source of water (both for cooling and water to be purified).
1.5.5 Hand tools for instrument adjustment (e.g. pliers).
1.5.6 Instrument instruction manuals.
1.5.7 Instrument logbook.
2.0PROCEDURES
2.1Maintenance and Usage Recommendations
2.1.1For troubleshooting and basic maintenance, refer to the instrument’s instruction manual.
2.1.2The study director (or PI, if applicable) shall ensure that equipment logbooks are prepared for Corning water purification systems, as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.
2.1.3The distillation unit is to be drained and cleaned when scale build-up is evident.
2.1.4Deionization cartridges are to be replaced when the red “change cartridge” light comes on.
2.1.5Ensure that the instrument’s electrical, water supply, and drainage requirements are met. Refer to the appropriate instruction manual for instrument specifics.
2.1.6Ensure that the instruments (e.g. deionizer – distillation unit) are properly connected to each other (refer to instruction manuals).
2.1.7 Any maintenance or repair made to the instrument must be recorded as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.
2.1.8Additional information pertaining to maintenance or repair may be appended in this section of the logbook and cross-referenced to the Maintenance and Repair Log entry using a sequential hand-numbered code (e.g. REF-001) written in the upper right-hand corner of the appended sheet.
2.1.9Maintain the instrument logbook, containing the current version of this SOP, temperature control records and maintenance repair logs, and associated instruction manuals in the immediate vicinity of the instrument.
2.2General Operation
The following describes the general procedure for using Corning MegaPure brand deionizers, distillation units and automatic collection systems. Please refer to instruction manuals for initial assembly / set-up.
2.3Deionozer (Corning MegaPure model D2)
2.3.1Normal Operation
2.3.1.1Ensure drain valve is “CLOSED” and operating mode is switched to “NORMAL”.
2.3.1.2Ensure the water supply valve on the instrument is “ON”. Turn on water supply (i.e. R.O. water supply) and adjust the flow control knob if necessary.
2.3.1.3Ensure that the green purity light is lit. If not (red “change cartridge” light is on), then the deionizer should be purged or the cartridges should be changed.
2.3.1.4To shut down, turn off thewater supply (i.e. R.O. water supply). Do not use the flow control knob to shut off the water supply.
2.3.2Purging
2.3.2.1Disconnect the deionizer from the distiller.
2.3.2.2To purge the deionizer, ensure that the drain valve is “CLOSED” and switch the operating mode to “PURGE”.
2.3.2.3Ensure the water supply valve on the insturment is “ON”. Turn on water supply (i.e. R.O. water supply) and adjust the flow control knob if necessary. Collect and discard the first 3-4 litres of treated water.
2.3.2.4Switch operating mode to “NORMAL” to resume regular operation.
2.3.2.5If, after purging, the red “change cartridge” light remains lit, change deionization cartridge(s).
2.3.3Changing Cartridges
2.3.3.1Disconnect the deionozer from the distiller.
2.3.3.2To change cartridges, shut off the water supply valve and open the drain valve. Allow the cartridges to drain.
2.3.3.3Loosen the cartridge housing closure knob, and remove / discard cartridges via regular garbage.
2.3.3.4Install new cartridges, as specified in the instruction manual. Re-secure cartridge housing closure knob.
2.3.3.5Purge the deionizer.
2.4Distillation Unit (Corning MegaPure model MP-6A)
2.4.1Normal Operation
2.4.1.1Ensure that the boiler drain stopcock is closed.
2.4.1.2Turn on source of water to be distilled. If this water is coming from a deionizer, ensure that it is on and functioning properly (see 2.3.1 above).
2.4.1.3Press the water switch. This automatically opens the solenoid valve to allow water into the boiler.
2.4.1.4Adjust flowmeter to the desired setting. 13 – 14 gallons per hour is recommended.
2.4.1.5Allow the boiler level to fill until water flows through the overflow tube.
2.4.1.6Press the operate switch to turn heaters on.
2.4.1.7Turn on cooling water. Distillate should be produced in approx. 30 min.
2.4.1.8When the desired amount of water has been distilled, press the off switch and shut off the cooling water and source water.
2.4.1.9If a residue develops inside the distillation unit, then cleaning is necessary.
2.4.2Cleaning
2.4.2.1Remove the distilled water collection bottle and replace with another bottle to collect waste water.
2.4.2.2Drain the boiler by opening the stopcock. Once boiler is drained, close the stopcock.
2.4.2.3Block the constant level overflow tube by tightening a pinch clamp around the tube, near its attachment to the glass pipe.
2.4.2.4Pour around 4L of approximately 10% hydrochloric acid into the top of the constant level chamber.
2.4.2.5Wait around 10 minutes or until residue disappears. If residue fails to disappear, turn heaters on for a few minutes until residue disappears. Do not boil.
2.4.2.6Drain the boiler by opening the stopcock. When drained, close the stopcock and loosen the pinch clamp on the overflow tube.
2.4.2.7Run the distillation unit (as in 2.4.1 above) for around 30 minutes. Discard distillate, and replace waste bottle with water collection bottle.
2.4.2.8If condenser coils become discoloured, remove condensor and flush with approximately 10% hydrochloric acid.
2.4.3Automatic Collection System (Corning model ACS)
2.4.3.1For assembly instructions, refer to the instruction manual.
2.4.3.2Take the necessary precautions to avoid overfilling or overflowing the collection bottle.
2.4.3.3To dispense water, turn the knob on the collection system to open. When the desired amount of water has been dispensed, turn the knob to close.
2.4.3.4Place a bucket or pan underneath the dispensor tube to collect residual water.
2.5Calculations
NA
2.6Documentation and Reporting
2.6.1The study director (or PI, if applicable) shall ensure that equipment logbooks are prepared for Corning water purification systems, as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.
2.6.2Any maintenance or repair actions taken on these instruments must be recorded as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment on the day that the action was taken and initialed by the person performing the maintenance or repair action.
2.6.3Any additional information pertinent to calibration, maintenance or repair activities (e.g. calibration sample data, quality control check sample data, certification report etc.) should be incorporated into the logbook in the appropriate section in chronological order. Sequentially number additional information sheets in the upper right hand corner for easy reference.
3.0DisTRIBUTION AND ARCHIVING
3.1distribution
3.1.1Official copies of this SOP shall be made by the DCO and distributed as follows:
(a)The original SOP and an exact copy shall be retained in the CFS-GLFC archive (copies 001 and 002).
(b)One copy shall be kept by the DCO in the DCO SOP manual (copy 003).
(c)One copy shall be kept by the QAU manager in the QAU manager SOP manual (copy 004).
3.1.2The DCO may distribute additional copies of this SOP to personnel engaged in the conduct of, or responsible for, the supervision of GLP compliant studies.
3.1.3The DCO shall announce the availability of new versions of this SOP within one week of the effective date, and shall distribute new versions by requiring that old versions be exchanged for the new ones. The DCO shall not release a revised SOP to recipients of prior versions unless it is exchanged for the previous version.
3.2Archiving
3.2.1It is the responsibility of the DCO to provide the signed original SOP (copy number 001), an exact copy (copy number 002) and an electronic copy of the final version of this SOP to the archivist for archiving as set forth in the current version of SOP No. M02004/004, Archiving Data and Test Materials.
3.2.2It is the responsibility of the study director to ensure that instruction manuals for the instrument and peripherals are archived upon retirement/disposal of the equipment.
3.2.3It is the responsibility of the Study director (or PI, if applicable) to ensure that all original equipment temperature control records, maintenance, repair and calibration log forms are transferred annually to the archive.
3.3Destruction of Outdated SOPs
With the exception of the original archived SOPs (copies 001 and 002) which are retained in the CFS-GLFC archive, the DCO shall assure that all other retired versions of SOPs are destroyed by shredding.
4.0ASSURING SOP VALIDATION AND COMPLIANCE
4.1Responsible Individual
4.1.1The QAU is responsible for assuring that this SOP is valid.
4.1.2The Study Director is responsible for assuring that this SOP is followed by persons using such equipment and that these persons have been appropriately trained in the use of this SOP.
5.0REVISION of the sop
5.1Responsible Individual
The QAU is responsible for assuring that this SOP is current. If necessary, the QAU manager shall initiate the revision process.
5.2Revision Schedule
5.2.1This SOP shall be revised when its provisions no longer agree with current practices or applicable regulations.
5.2.2If this SOP requires revision, it shall be revised according to the procedures set forth in the current version of SOP No. M02004/001 Writing Standard Operating Procedures and approved within 45 calendar days of initiation of the revision process.
6.0CONTINGENCIES
When personnel find circumstances that do not permit compliance with this SOP, they shall consult the study director or the QAU manager within 24 hours.
7.0CONFIDENTIALITY
All SOPs are considered confidential and shall be handled accordingly. They are not to be copied or made available to outside parties without proper safeguards and the approval of management.
8.0References
(a)OECD Principles of Good Laboratory Practices, 1998.
(b)CFS-GLFC Emergency and Fire Safety Manual.
(c)SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.
(c)SOP No. M52506/014, The Use of Personal Protective Equipment.
(d)SOP No. M52506/015, The Safe Handling of Hazardous Materials.
(e)SOP No. M02004/004, Archiving Data and Test Materials.
(f)SOP No. M02004/001, Writing Standard Operating Procedures.
(g)Instruction Manuals
9.0APPENDICES
NA
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