TITLE: Maintenance and Operation of Ultrasonic Cleaners

TITLE: Maintenance and Operation of Ultrasonic Cleaners

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 ultrasonic cleaners 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 ultrasonic cleaners in the conduct of a GLP compliant study.

1.3Definitions

Certified or Calibrated Thermometer – A thermometer which has been certified according to a national standard or calibrated against a reference thermometer that is traceable to a national standard.

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 Plan – A document that defines the objectives and experimental design for the conduct of the study, and includes any amendments.

Study Director - The individual responsible for the overall conduct of the non-clinical health and environmental safety study.

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).

Ultrasonic Cleaner – An instrument used to clean equipment through the use of ultrasonic sound waves.

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 in the laboratory in accordance with the current version of SOP No. M52506/015 The Safe Handling of Hazardous Materials.

1.4.3 Decanting, transfer or other handling of large (>500 mL) containers of solvents must be conducted in an approved, operational fume hood. Fume hoods should be approved or certified annually.

1.4.4 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.

1.4.5 Never operate the unit without water in the tank.

1.4.6 Exercise caution when using solvents and flammable liquids in the tank. Such liquids, if used for cleaning, should be contained in a vessel (e.g. beaker) such that it will nor overflow once items to be cleaned are submerged.

1.4.7 Ensure that the liquid level in the tank is at least approx. 2.5cm deep.

1.4.8 Make sure the unit is grounded.

1.4.9 Never place your fingers in the tank when it is in operation.

1.4.10 Keep the area around the unit clean and dry.

1.5Materials

The critical materials required to operate and maintain the dry bath include:

1.5.1 Deionized or distilled water.

1.5.2 Ultrasonic cleaner instruction manual.

1.5.3 Equipment logbook for ultrasonic cleaner.

1.5.4 Thermometer, traceable to a national standard (e.g. National Institute of Standards and Technology).

2.0PROCEDURES

2.1Maintenance

2.1.1When the ultrasonic cleaner does not operate properly (e.g. temperature,fluctuation, lack of heat), refer to the ultrasonic cleaner’s instruction manual for basic troubleshooting.

2.1.2For parts replacement or other maintenance, refer to the instruction manual. Some maintenance and repair procedures (ie. Temperature calibration) may require a qualified electronic service person as described in the instruction manual.

2.1.3Any 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.

2.1.4Maintain the instrument logbooks as set forth in the current version of SOP No.M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.

2.2General Operation

The following describes the general procedure for using ultrasonic cleaners. Please refer to the instrument’s instruction manual for instrument-specific procedures.

2.2.1Fill the tank with distilled or deionized water such that it will not overflow once items to be cleaned are submerged.

2.2.2Place items to be cleaned inside the tank.

2.2.3Turn the unit on.

2.2.4Set the desired water temperature (if applicable), as specified in the study plan. For room temperature, set the water temperature at around 20°C. Temperature measurements shall be determined using a certified or calibrated thermometer and documented as set forth in 2.3.1

2.2.5Set the desired cleaning time (if applicable), as specified in the study plan. For continuous operation, do not specify a time.

2.2.6Start the instrument (e.g. press the start/stop button).

2.2.7When the items are clean, turn ultrasonic operation off (e.g. press start/stop button), or allow the timer to run out (if a time has been set).

2.2.8Remove items from the tank.

2.2.9Turn power off at the end of cleaning or at the end of the day. For cleaning the interior and exterior of the ultrasonic cleaner, use a mild solution of soap and water. Prior to cleaning, disconnect the power supply.

2.2Calculations

NA

2.3Documentation and Reporting

2.3.1Thermostat setting and water bath temperature will be monitored at least daily while the instrument is in use (provided that water bath temperature is critical for a specific use), and recorded on the Temperature Control Record as set forth in the current version of SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment. The thermometers used must be certified or calibrated against a reference thermometer that is traceable to a national standard.

2.3.2Any maintenance or repair actions taken on this instrument, including calibration, 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.

2.3.3Any 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. M52506/014, The Use of Personal Protective Equipment.

(d)SOP No. M52506/015, The Safe Handling of Hazardous Materials.

(e)SOP No. M52506/001, Preparation and Use of Logbooks for Repair, Maintenance and Calibration of Equipment.

(f)SOP No. M02004/004, Archiving Data and Test Materials.

(g)SOP No. M02004/001, Writing Standard Operating Procedures.

(h)Ultrasonic Cleaner Instruction Manual.

9.0APPENDICES NA

Page 1 of 6