Qualification, calibration and maintenance of stability chambers. Dr. Mathias Kramer
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1 Qualification, calibration and maintenance of stability chambers Dr. Mathias Kramer
2 Agenda 1. Qualification of stability chambers 2. Calibration of equipment of stability chambers 3. Maintenance of stability chambers
3 Qualification 1. Qualification of stability chambers 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
4 Qualification general aspects Qualification = Project management define good Team-Members, experts where needed QA, Engineer, technician, system owner (teamleader) the team determines your success approach: planning doing reporting using professional project management Tool (MS-Project) define milestones arrange periodical status- meetings
5 Qualification general aspects MS-Project-Plan:
6 Qualification 1. Qualification of stability chambers 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
7 Qualification User Requirement Specification URS: Document to collect all requirements define usage very precisely (which kind of samples will be stored?) define climatic condition -nominal value, according ICH Q1A, WHO (e.g. accelerated conditions: 40 C ± 2 C / 75 % r.h. ± 5 % r.h.) - limits, according ICH Q1A, - additional conditions (e.g. Humidity in 5 C-Cells is not recommended, but very important)
8 Qualification User Requirement Specification URS: Document to collect all requirements define location, shape and area needed define equipment (shelves, drawer needed?) define safety and enviromental aspects (fire detector) define security requirements (on-line monitoring, locking system) define budget define basis and scale of qualification
9 Qualification analysis of local conditions Find the best location (building) for stability chambers consider flow line (Short way, minimal horizontal moving) infrastructure (water, air condition, additional deconstruction) safety and enviromental aspects (energy saving) security requirements (available access control-systems)
10 Qualification 1. Qualification of stability chambers: 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification
11 Qualification overview Qualification of a (new) climatic chamber: 4 Qualification Phases 1.Phase 2.Phase 3.Phase 4.Phase MQP DQ IQ OQ PQ MQR MQP: Master-Qualification Plan MQR: Master-Qualification Report DQ: Design Qualification IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification
12 Qualification 1. Phase: DQ-Design Qualification Start need of a climatic chamber write and approve DQ-Plan getting different tenders Check technical manuals URS available write and approve DQ-Report (with reported open issues) before starting IQ End Order of the designed chamber
13 Qualification 2. Phase: IQ-Installaltion Qualification Start delivery of the climatic chamber write and approve IQ-Plan compare ordered and delivered material Installation of the climatic chamber according local requirements / standards first function check prepare a (technical) logbook Installation of additional equipment (monitoring sensor or flash-light) write and approve IQ-Report (with reported open issues) before starting OQ End installed climatic chamber
14 Qualification 3. Phase: OQ-Operational Qualification Start installed climatic chamber write and approve OQ-Plan OQ-tests with empty chamber: running of the climatic cell: does it work as expected perform extensive Temperature- and Humidity-Room-Mapping testing any influence of the climatic conditions (light, open doors) simulate a power failure and protocol the behavior of the chamber to make conclusions find a representative position for the monitoring sensor write and approve OQ-Report (with reported open issues) before starting PQ End Climatic chamber ready for operation
15 Qualification 4. Phase: PQ-Performance Qualification Start running / working climatic chamber (without samples) write and approve PQ-Plan repeat the OQ-tests with filled chamber: running of the climatic cell: does it work as expected perform extensive Temperature- and Humidity-Room-Mapping testing any influence of the climatic conditions (light, open doors) simulate a power failure and protocol the behavior of the chamber to make conclusions Go live with the on-line monitoring, if available Calibrate the sensors write + approve PQ-Report (without any open issues) End completely qualified climatic chamber
16 Qualification 4. Phase: PQ-Performance Qualification perform extensive Temperature- and Humidity-Room-Mapping Possible data logger positions to map temperature and humidity
17 Qualification data logger to collect temperature and humidity data
18 Qualification 1. Qualification of stability chambers: 1.1 General aspects 1.2 URS, analysis of local conditions 1.3 Qualification: DQ, IQ, OQ, PQ 1.4 periodic Re-Qualification 2. Calibration of equipment: 3. Maintenance of stability chambers:
19 Qualification Periodic Re-Qualification Start running climatic chamber Strategy: Review of qualification status after a pre-defined time period write and approve Re-Qualification-Plan check all relevant parameters (i.e. MSR) is the change documentation complete? Repeat the Temperatur- and Humidity- Room-Mapping write and approve PQ-Report before writing the Final Report End re-qualified climatic chamber
20 Calibration 1. Qualification of stability chambers 2. Calibration of equipment of stability chambers 3. Maintenance of stability chambers
21 Calibration concepts Calibration of equipment (e.g. sensors for on-line monitoring) in place Calibration including whole measured distance one point calibration at set point Calibration of equipment (e.g. data-logger for temperature mapping) with a certified, adjusted master tool (Certified Institution) Calibration without measured distance Multi point calibration all set points must lie within calibration range Data logger must be suitable for intended conditions (e.g. 40 C / 75%r.H.)
22 Maintenance 3. Maintenance of stability chambers 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
23 Maintenance periodical Maintenance, technical support Defined maintenance according service-protocol: checking pressure, air flow, valves on-going maintenance including auxiliary media (steam, cooling water) support in any case of emergency, 24h a day
24 Maintenance service-protocol to document pressure
25 Maintenance 3. Maintenance of stability chambers: 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
26 Maintenance microbiological monitoring and cleaning periodical microbiological monitoring according written procedure periodical cleaning of stability chambers including according written procedure, e.g. every 6 months define acceptance criteria
27 Maintenance 3. Maintenance of stability chambers 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
28 Maintenance on-line monitoring (Temperature and Humidity) confirm the defined position for any monitoring sensor which is used to visualize the climatic conditions, generating GMP-Data to document any deviations Date could be requested by inspectors monitoring sensors are calibrated annually
29 Maintenance on-line monitoring (calibrated sensor)
30 Maintenance 3. Maintenance of stability chambers 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
31 Maintenance Alarm Systems double- control of the climatic limits using another, different, independent alarm system
32 Maintenance 3. Maintenance of stability chambers 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
33 Maintenance Change Control Approved changes Planned change has to be assessed Relevant changes have to be approved by Quality Assurance before realization Emergency changes Approved by Quality Assurance after implementation of the change
34 Maintenance 3. Maintenance of stability chambers 3.1 periodical maintenance, technical support 3.2 microbiological monitoring, cleaning 3.3 on-line monitoring 3.4 Alarm-System 3.5 Change Control 3.6 Temperature- or Humidity-Deviations
35 Maintenance Temperature- or Humidity Deviations Short time deviations are allowed by ICH ( short term spikes due to opening of doors are accepted as unavoidable ) important deviations have to be documented (i.e. in a Deviation Report ) according ICH ( Excursions that exceed the defined tolerances for more than 24 hours should be describes in the study report )
36 Stability Chambers Overview F. Hoffmann-La Roche (post approval) all ICH conform conditions are available Chamber KTZ 1, 8, 10 KTZ 4 Conditions T ( C) r. H. (%) KTZ 3, KPS E +I KTZ 5 KTZ
37 Stability Chambers Example: 25 C/60% r.h. Chamber
38 Stability Chambers Example: 25 C/60% r.h. Chamber drawer
39 Stability Chambers Example: 5 C climatic chamber Calibrated online monitoring sensor (Pt100)
40 Stability Chambers Example: 25 C/60% r.h. climatic chamber Flash light (emergency case) Calibrated on-line monitoring sensor (Temperature and Humidity)
41 Stability Chambers Example: 25 C/60% r.h. climatic chamber access controlsystems escape route ramp
42 Dr. Mathias Kramer Thanks for your attention!
43 We Innovate Healthcare
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