Weighing Area Module
This specific module includes the weighing area prepared for:
Weighing raw material before formulation.
Module’s general characteristics as per Base Clean Room Module:
Clean room level:
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).
Classified ISO 8 as per ISO 14644 (Class D GMP).
Clean room panels and finishing as per SAMPU standards.
Technical level:
Technical area installed above including HVAC ducts, cables and piping.
Total combined height of clean room level + technical level is 4,5 m.
Laminar flow cabin
Laminar flow cabin to create controlled environment under laminar flow.
Including:
Controlled environment 1,6 m x 1,6 m x 2,2 m.
Return column with grid near floor level.
EC fan 4.200 m3/h.
Automatic air speed control at 0,45m/s ± 20% following GMP standard for laminarity of air.
Filtration layers:
Pre-filter COARSE-90% as per ISO 16890 (G4 as per EN779).
Filter ePM10-55% as per ISO 16890 (M6 as per EN779).
Terminal HEPA filter H14 as per EN 1822.
Positive or negative pressurization of the cabin in relation to environment (parametrizable).
Lighting to guarantee >500 lux on all working surfaces.
Air speed monitoring.
Filter clogging warning.
Antistatic transparent plastic curtains.
Control of cabin integrated with HVAC system behavior.
Weighing scale
Included 2x weighing scales:
60 kg / ± 2 g.
3 kg / ±0,5 g.
Installed on an stainless steel workbench.
Pharmaceutical Compressed Air (PCA) Point of Use for cleaning.
OPTIONAL inert gas Point of Use.
HMI
Information retained with data integrity complying with CFR 21 Part 11.
Prepared to generate:
Batch report.
Alarms report.
Audit trail report.
Remote connection for aftersales services.
Design and Manufacturing criteria
Operable by maximum 2 people.
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.
