Cleanroom-Requirements according to Annex 1, EU-GMP-Guidelines Strict requirements for compliance with the environmental conditions in the relative cleanroom classes Continuous data recording and archiving of the measured variables room temperature, relative humidity, differential pressure and particle load Cleanroom Classes A/B C D Test Frequency Continuously Hourly up to monthly Daily up to yearly 2
General requirements on a GMP-compliant monitoring system Complete recording of the measurement raw data Forgery-proof archiving and traceability Alarm when limits are exceeded Customized reports daily, weekly and monthly Batch-related protocols Investment protection by using standards Flexible system expandability Consistent GMP documentation for audit safety and high quality 3
Special features of the on/off monitoring system From planning to service all from one source Use of Siemens hardware and software components (also on VMWare platform) Standardized reporting (batch, cyclical, temporal) Modern confirmation procedure (with/without comment, rating possibility) Web capability, print from the web client Consistent planning and configuration tool Modular setting and expandability 4
Modular Design System Layout Monitoring Server Monitoring Client Automation Station Network 5
Modular Design Highlights Up to 32 monitoring clients at one server Access by web possible with iexplorer Several automation stations for distributed systems Data transfer from external systems via Modbus, Profibus and OPC Long-term archive server Standard reporting system Data buffering 6
Modular Design Measuring Point Analog values (temperature, pressure, flow, humidity) Particle sensors: Ethernet TCP, Modbus or serial Operating states of infrastructure equipment (air conditioning, etc) 7
Modular Design Functions Use of an on/off standard module library, which is developed, qualified and documented based on GAMP5 This includes for example: Analog value monitoring module Particle sensors control module Vacuum pump control module Light & horn control module Time synchronization module Connection monitoring module 8
System Structure Example: Sensors, I/O level, AS, server, clients 9
System Functions Example: Building overview 10
System Functions Example: Room overview 11
System Functions Example: Room display for sensors (temperature, humidity, pressure) 12
System Functions Example: Trend graph with alarm 13
System Functions Example: Alarm list 14 Standard-Monitoringsystem
System Functions Example: Operating list / Audit trail 15 Standard-Monitoringsystem
System Functions Example: Faceplate operating modes, PV, gradient 16 Standard-Monitoringsystem
System Functions Example: Faceplate alarm limits, time delay 17
System Functions Example: Faceplate Hysteresis, offset, lowpass 18
System Functions Example: Monthly report 19
System Functions Example: Batch report 20
GMP Continuous Life Cycle User Requirement Specification (URS) User Requirements Project planning & Assembly Planning hardware Control panels assembly Software design Basic Design Functional specification FAT Hardware Test Basic system specification and system overview Quality management: QPP, risk analysis Software Test Quality management: IQ tests, IQ report Detail Design HW Design Specification (HDS) Commissioning Functional control of the complete system in the plant SW Design Specification (SDS) OQ: test of critical parameters and functions according to DQ Quality management: DQ tests, DQ report Quality management: OQ tests, OQ report Final documentation 21
GMP Risk-based approach, that means the individual user requirements are evaluated with the corresponding risk levels and appropriate tests are focused on Consistent traceability of user requirements from specification up to necessary tests and their acceptance Maximum of standardized functionalities GAMP-compliant documentation up to the appropriate IQ/OQ tests from a single source Customized approach to qualification (orientation according to the respective SOPs) 22
Conclusion Project security at the introduction of the monitoring system due to the high experience in IT and GAMP5 Independent system supplier with a focus on the entire plant that is manufacturing and monitoring with connection of single instruments and equipment Ensuring of a modern qualification life cycle and qualification documentation according to GAMP5 Warranty, maintenance and calibration service Good price/performance ratio Good references in the pharmaceutical industry 23
Thank you for your attention! Always all values under control! 24