VAL-025 Validation of Laboratory Instruments

1. Responsibilities During Validation

2. General Requirements

2.1. Laboratory instrument/equipment provide accurate and precise quantitative and qualitative analytical results for organic, inorganic and biological products.

2.2. The level of Validation/Calibration documentation required for each piece of equipment is assessed based on the testing methodology used, complexity of the instrument, and the analytical function of the equipment.

2.3. For Laboratory instrument/equipment containing differing components, e.g. HPLC, an overall validation approach, rather than qualifying each component is permitted.

2.4. Suppliers of laboratory instrument/equipment may have validation packages as part of the instrument/equipment purchase, available with accompanying reporting and provide durables and consumables designated for validation/re-validation purposes.  Reference standards provided and used in the validation process must be certifiable and traceable.

2.5. The following factors are part of the validation documentation for new laboratory instrument/equipment:

2.5.1. The supplier provides documents regarding the principles and benefits of the instrument/equipment being purchased including working requirements, validation, calibration and maintenance guidelines.

2.5.2. An instrument/equipment demonstration must also be provided. The instrument/equipment manufacturer will provide pre-installation manuals or written advice when installation of services is required.

3. Installation of New Instrument

3.1. Checking the instrument/equipment

Laboratory instrument/equipment is usually received in a configured container as designed by the manufacturer.  Unpack carefully according to the manufacturer’s instructions noting any part that is missing, broken or damaged.  Compare and check off the parts and accessories received to the checklist as purchased.  Confirm that the equipment is complete and in good condition.  Notify the supplier/manufacture immediately of any problems found.

3.2. Setting up considerations

3.2.1. Laboratory equipment/instrumentation can be sensitive to certain environmental factors.  By observing the following factors during installation, the Operator can minimise the effects of these influences where appropriate:

a. Location near output of air conditioner causing excessive drafts;

b. Direct sunlight and other high temperature locations, i.e. near an oven or furnace;

c. Vibrations through the Laboratory bench.

For further considerations always consult the instrument manual and the Equipment Service Technician/Engineer for any further requirements.

3.2.2. Some electrical precautions should be observed, (refer to the instrument manual for any special requirements for each particular instrument and consult the Equipment Service Technician):

a. Avoid using an extension cord where possible.

b. Don’t place the unit in the same circuit with large electrical motors.

c. Plug all line cords into a surge protector.

3.2.3. Observance of two basic Housekeeping rules.

a. To allow a unit to cool properly, keep the vents on the back clean.

b. Minimise the unit’s exposure to dust and provide sufficient bench space for the instrument and the computer, printer and keyboard.

3.2.4. Allow enough space nearby for sample handling.

3.3. Attachment of modules

3.3.1. Certain laboratory equipment/instruments are designed to provide full flexibility and modules can be attached.

3.3.2. Section 1 to 3 should also be considered when installing modules.

3.4. Hardware and Software orientation

3.4.1. Installation of the software may be carried out by the supplier at point of purchase or on-site installation.

4. Method Validation Documentation

4.1. Validation Tests performed In-house

4.1.1. The Validation documentation follows a similar format to the validation requirements of SOP VAL-005, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).  The extent of documentation required is dependent on the function of the particular instrument being validated.  For simple instruments the Validation document can combine IQ/OQ/PQ into the one document and for more complicated equipment separate documents will be required.  For particular applications only the OQ or PQ tests need to be performed.

4.1.2. SOP VAL-005will be used as a guide when developing the validation documentation:

4.2. Validation Tests provided/performed by Instrument Supplier

For validation packages provided by the instrument supplier the package must be assessed for suitability to in-house requirements.  If found to be unsuitable a new document using the appropriate in-house format of IQ/OQ/PQ must be used by transferring the relevant useful validation protocols from the supplier’s documentation.

5. Certification Records

5.1. Certification documentation relating to the equipment used to perform the laboratory equipment acceptance tests is documented in the validation file.  Good Laboratory Practice (GLP) requirements concerning volumetric glassware, pipettes and flasks are applied using clean glassware; calibrated automatic pipettes/dispensing equipment, performing work at the correct temperature.

5.2. Auxiliary instrumentation /equipment used to do the testing to have full calibration and maintenance records.

6. Post Installation Activities

6.1. All relevant SOP’s regarding operation, calibration, validation and maintenance and a training module will be written prior to the instrument/equipment being signed off for regular laboratory use.

6.2. All Laboratory Technicians using the new laboratory instrument/equipment will be trained in the use of instrument/equipment using the relevant Training Module and Standard Operating Procedures (SOP).

7. Re-Validation and Calibration

A Performance Qualification can be used by a Laboratory Technician at regular intervals to confirm that the instrument continues to operate to specification following the methods as supplied by the manufacturer to confirm that the working system remains in validation.  On-going tests are filed in the validation report.

7.1. Re-validation will be required when:

7.1.1. The equipment/instrument is moved requiring re-installation.

7.1.2. If the instrument manufacturer requires it after the yearly routine maintenance by the equipment/instrument manufacturer has been performed.

7.1.3. The equipment/instrument appears to be out of calibration (see SOP LAB-005).

Routine calibration schedule is planned with specific SOPs controlling the calibration and maintenance of the instrument/equipment.

8. Routine Maintenance and Servicing

8.1. An equipment maintenance record is set up for each piece of instrument/equipment.

8.2. The Manufacture/supplier of the equipment/instrument may provide instructions for Laboratory Technicians to do routine maintenance or a service plan may be provided by the manufacturer/supplier.  If this is not provided, the Laboratory Technician must set up the routine maintenance requirements in consultation with the instrument/equipment manual equipment, Service Technician and the relevant requirements of GLP.

8.3. Deviation Records (DR) are raised where computerised systems malfunction or functional issues need to be addressed.

9. Summary of Changes