HVAC Module
This specific module includes the HVAC equipment:
Air Handling Unit to provide HVAC to up to 10 modules. This means:
Control air flow: ≥10 renovations/hour following requirements for Class D GMP.
Control air temperature: 20 ± 3ºC.
Standard for outdoor conditions HOT 40ºC / 75% HR.
Standard for outdoor conditions COLD 5ºC / 75% HR.
Control fresh air proportion: 15 ± 5%.
Control air filtration: ePM1-85% as per ISO 16890 (F9 as per EN779).
Control room overpressure: from +10 to +30Pa.
Module’s general characteristics as per Base Clean Room Module:
Dimensions:
External: 5,84 m x 2’35 m x 2’6 m (Length x Width x Height).
Internal: 5,72 m x 2’23 m x 2’5 m (Length x Width x Height).
Non-classified area.
HVAC module elements
Air Handling Unit: the core of the HVAC. Is comprised of the following elements:
Structure:
Insulated and airtight following EN 1886 standards:
Casing air leakage (-400 / +400 / +700 Pa): L1(M)/L2®.
Thermal transmittance: T2.
Thermal Bridging: TB2.
Fan:
Direct-driven EC type (low noise and low maintenance).
Capacity to blow up to 4.800 m3/h.
Sized to beat all pressure drops on SAMPU system.
Cold battery:
Runs with chilled water 7/12ºC, distributed on black utilities module (see details here).
Drainage included to remove condensation.
Hot battery:
Runs with electrical resistance as an standard.
OPTIONAL: if there is an existing network of Hot Water or Industrial Steam, the AHU can be adapted to these utilities instead.
Filters:
Pre-filter COARSE-90% as per ISO 16890 (G4 as per EN779).
Filter ePM10-55% as per ISO 16890 (M6 as per EN779).
Filter ePM1-85% as per ISO 16890 (F9 as per EN779).
All filters equipped with pressure switch to detect clogging.
Ducting system:
Following the standards of SAMPU (see details here).
Control panel:
HMI of 15”.
Monitoring of all values:
Pressure on each room.
Pressure on AHU’s fan.
Temperature & Humidity on return duct.
Temperature & Humidity on impulsion duct.
Filter clogging status.
Airlock door status & interlock (see details here).
HMI
Information retained with data integrity complying with CFR 21 Part 11.
Prepared to generate:
Historic report.
Alarms report.
Audit trail report.
Remote connection for aftersales services.
Design and Manufacturing criteria
HVAC system can run autonomously 24/7 without human intervention.
Air Handling Unit + Ducting network designed following ISO 14644 standards.
According to regulations:
European Commission Vol. 4 EU Guidelines to Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use.
Good Manufacturing Practices of the Food and Drug Administration (FDA).
21 CFR Part 11 “Electronic Records, Electronic Signatures”. Food and Drug Administration Title 21 of the Code of Federal Regulations.
Equipment Directive 2006/42/EC.
EN ISO 14122: Safety of machinery - Permanent means of access to machinery, part 1 till 4.
EN ISO 13849: Safety of machinery - Safety-related parts of control systems.
Documentation
Design documentation.
DQ protocol + report.
As-built documentation:
CE Declaration of Conformity.
Layouts.
Electrical diagram.
Pneumatic diagram.
Datasheet of valves and/or instrumentation and components.
Calibration Certificates.
Operation manual:
Start-up procedure.
Format changeover procedure.
Cleaning procedure.
Alarms list with every troubleshooting.
Maintenance manual.
Spare parts list and fungible assets.
FAT & SAT protocols + report.
IQ & OQ protocols + report.
PQ protocol + report.
The standard language of all documentation will be English.
