Facility and Equipment Maintenance

Deborah L. GriffinManager, Quality Assurance for Cellular Therapies

Hillman Cancer CenterUniversity of Pittsburgh Cancer InstituteUniversity of Pittsburgh Medical Center

Overview

• Facility Maintenance• Equipment Maintenance

Facility SpecificationsDrawing on our design talk from earlier…

If possible: documentation of construction

Correspondence with architects, their plans & specifications, construction agreements

Correspondence with FDA, if applicableCorrespondence with internal facilities

management

Facility SpecificationsDuring construction:

Monitoring of: Materials used in constructionDesign changesDamage occurring during construction General inspectionsContinued correspondence and progress

reports

Facility SpecificationsUpon completion of construction

Documentation of: Final walk-thru checklistResolution of checklist items Qualification/Validation of critical items:

Air handling systemTemperature and humidity controlsCard key access systemAutomated LN2 delivery systemAlarm systemsEmergency power and back-up systems

Final hand-off of new laboratory: date of start-up of operations

Facility Operations Once in production…

Documentation of critical systems Quality Control semi-annually

Air handling systemEmergency power and back-up systemsAlarm systems

Quality Control more frequently than1x/monthTemperature and humidity controlsViable and non-viable particle countsAir pressure differentialsAutomated LN2 delivery system

Ongoing monitoring of the physical condition of the laboratory

Facility Operations Preventative maintenance and deviation

management: Documentation!!!Preventative maintenance

Any servicing performed on the facility such as replacement of HEPA filters or temperature checks or adjustmentsSafety inspectionsElectrical checks

Deviation ManagementAny repairs due to facility damage or failure such as air

handling vents needing to be replacedSticking doors, cracks in wall due to settling of

foundation, etc!Ask for documentation of everything!

Equipment Overview

• Purchase• Installation• Qualification• Validation• Maintenance• Retirement• Document control

Equipment Purchase

When purchasing equipment, think of long-term use. Compare products.Ask trusted colleague for advice.Buy a clinical product if available

Receipt of Equipment

Documentation of: Date of receipt and initials of accepting

tech entered into ordering log book or other inventory system

Inspection of packagingAny evidence of visible physical damage

Unpacking equipment

Assistance of factory vendor representative, if major equipmentDocumentation of:

Correct equipment shippedAll accessories presentInspection of equipmentAny evidence of visible physical damage

Internal Asset Control

Notify Clinical Engineering Perform electrical and safety testing Asset management

Computerized equipment inventoryPreventive maintenance schedule

Control tag placed on instrument indicating it has passed inspection

Documentation

Type of Equipment:

Equipment Manufacturer Model number Vendor

Date ordered Tech: *Attach copy of Purchase Req.

Receipt

Date of Receipt: Time of Receipt: Carrier:

Inspection of Packaging Acceptable Unacceptable (see F42) Tech:

Entered into Inventory Log Book Tech:

Installation

Unpacking performed by:

Factory Vendor/Service Rep present: No Yes, Name

Inspection of Equipment Acceptable Unacceptable (see F42) Tech:

Inspection of Accessories Acceptable Unacceptable (see F42) Tech:

Clinical Engineering

Clinical Engineering contacted: Date: Time: Tech:

Electrical and Safety Assessment Acceptable Unacceptable (see F42) Tech:

Asset Management Inventory Number PM Due

Signature of Tech Completing Form: Date:

Director Analysis: Initial Installation Acceptable Unacceptable (see F42)

Director Comments:

Laboratory or Medical Director Signature: Date:

Installation of EquipmentPosition in logical areaPlug into dedicated circuits or

emergency power if necessaryInstall according to manufacturer's

instructions Assure proper start up and general

operation

Priority of EquipmentDetermine

priority levelCritical piece

of equipmentor

One of many

Priority EquipmentA CytometerA Hematology AnalyzerA Scientific BalanceA Biological Safety Cabinets A Floor model CentrifugeA Cell washerA LN2 Transport ContainerA LN2 Vial VesselA Cryogenic Control Management & Fill SystemA LN2 Vessels (1 -> 5)A Cell SeparatorA Control Rate Freezers A Heat SealerA Active Blood Bank RefrigeratorA Sterile Connecting DeviceA Transplant Water BathsA Particle MonitorA Centrifuge inserts for CBUsB SerofugeB Dry ShipperB Fluorescent MicroscopeB Brightfield MicroscopeB PipettorsB Quarantine Blood Bank RefrigeratorB Vial CoolersC CO2 IncubatorC -70 FreezerC Clean Room FridgeC Clean Room FreezerC Stopwatches and TimersC Thermometers

Equipment QualificationLab “rules” (SOP)

Laboratory equipment that is to be used for assay validation must be qualified according to a pre-approved protocol prior to the start of method validation.

A document of the instrument qualification is to accompany any resulting method validation report.

Qualification PlanThe Qualification Plan must be documented

prior to performing any tests PrincipleGoalReagents and Supplies Procedure

Manufacturer’s TestsInternal Tests

Target Values/Acceptance standardsResult ReportingQuality ControlReferences and Appendices

Manufacturer’s TestsDetermine manufacturer’s tests prior to

instrument releaseExamples:

Electrical testing CalibrationReproducibilityCarryover

Internal TestsDetermine required tests prior to lab

instrument release, document in Qualification Plan, prepared specifically for each new piece of equipment, and depends on critical nature of equipment

Examples:Linearity Accuracy and PrecisionStabilityCross-validation

Qualification TestingQualification:

Testing performed according to specifications.Record test results in a spreadsheet or

database, as appropriate. When critical equipment:

Run in parallel on other qualified machinery in lab (if replacement or an additional unit).Run in parallel with other certified

laboratories (when a new piece of equipment).

Documentation ReviewReview of Qualification Plan and specified parametersCompilation of test resultsStatistical analysis of test resultsSummary of test resultsReport prepared by technologist detailing the results of the qualification

Laboratory Director reviews all documents and signs off on Qualification, specifying an implementation date. The Equipment Qualification Report is placed into the appropriate Equipment Binder.

Equipment BinderEach Binder contains five sections and is specific to equipment type. (e.g. Centrifuges, Microscopes, Refrigerators)

Procedures (QC, maintenance, cleaning, calibration) QC ResultsPM DocumentationDeviation Management (failures, malfunctions, accidents, servicecalls)Validations (qualifications, method validations and manufacturer’s manuals)

At this point we meet as a group to discuss Method Validation and required QC Procedures with the Laboratory Director. These documents will also be filed in the Equipment binder once complete and approved.