SAMPU | Standard pharmaceutical modules

Utilities Modules

This specific module includes Black Utilities storage + Distribution systems.

There are 2 kinds of black utilities for SAMPU systems:
- Cold Water (CW).
- Compressed Air (CA).
Concerning generation, SAMPU system can integrate with existing equipment. If needed, SAMPU can also provide these generation equipment as a complement.

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.

CW is used for:
- To cool down the temperature of the product inside the reactors.
- Regulate the HVAC air conditioning.
- To cool down the temperature of the PW loop.
CW is used on:
- Manufacturing Module.
- Holding Reactor Module.
- HVAC Module.
- Clean Utilities Module.
CW station includes:
- 1000 l tank, to store externally produced CW:
  - Made of stainless steel 304.
  - Level measurement.
  - Insulated.
- Pump couple, to keep the loop always moving:
  - 2x pumps in parallel, working in shifts.
  - Automatic switching between pumps.
  - 22.000 l/h at 2,5 barg.
- Expansion Tanks.
- Flow, pressure and temperature monitoring.
CW is kept and distributed using a closed loop:
- Starts on the tank.
- Traverses all the modules where CW is needed through the technical space (see details here).
- Ends on the tank.
- Water is always in movement. To ensure a well-functioning of the loop, it is provided with:
  - Balancing Valves.
  - Y-Filters.
  - Expansion Tanks.
  - Automatic Purges.

CA is used for:
- To be converted into PCA.
- To operate pneumatic devices such as valves or pistons.
CA is used on:
- Manufacturing Module.
- Holding Reactor Module.
- Sampling Area Module.
- Weighing Area Module.
- Filling Module.
- Feeding Bottles Module.
- Labelling Module.
- Automatic Cartoning Module.
- Case Module.
- Washing and Storage Module.
- Laboratory Module.
- HVAC Module.
- Clean Utilities Module.
- Black Utilities Module.
CA station includes:
- Flow monitoring.
- 1000 l tank.
  - Made of inox 304.
- Pressure regulation valve + filter.
- Pressure monitoring.

All pipes in contact with black utilities:
- Made of stainless steel 304.
- Pressure tested.
- No threaded connections.
Black Utilities systems can run autonomously 24/7 without human intervention.
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.

Centralized HMI to monitor and control all the stations of Black Utilities Module.
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 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.