Clean Utilities Module
This specific module includes Clean Utilities storage + Distribution systems.
There are 3 kinds of clean utilities for SAMPU systems:
Purified Water (PW).
Pharmaceutical Compressed Air (PCA).
OPTIONAL: Other inert gases, such as Nitrogen (N2) or Carbon Dioxide (CO2).
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.
Purified Water (PW)
PW is used for:
As the base for aqueous medicines.
Washing surfaces in contact with the product (equipment, pipes, tools and accessories).
PW is used on:
Manufacturing Module.
Holding Reactor Module.
Washing and Storage Module.
Laboratory Module.
PW supplied must be Pharmacopea compliant.
PW station includes:
1000 l tank, to store externally produced PW:
Level measurement.
Sprayball.
Sterile vent filter 0,22 µm.
Pressure Safety Valve.
Centrifugal pump couple, to keep the loop always moving:
2x pumps in parallel, working in shifts.
Automatic switching between pumps.
4.500 l/h at 3 barg.
Heat exchanger:
With cold water to keep loop temperature at 15 - 20ºC during operation.
Also, with electrical resistance to sanitize at 85ºC.
OPTIONAL: if there is an existing network of Hot Water or Industrial Steam, the heat exchanger can be adapted to these utilities instead.
Ultra-Violet dosing, to keep microbial growth at check.
Flow, pressure temperature and conductivity monitoring.
Total Organic Carbon (TOC) inline monitoring, fully automatic.
PW is kept and distributed using a closed loop:
Starts on the tank.
Traverses all the modules where PW is needed through the technical space (see details here).
Ends on the tank.
Water is always in movement in turbulent flow. No dead legs (3D>L) that could lead to microbial growth.
Pharmaceutical Compressed Air (PCA)
PCA is used for:
Pumping product.
Drying after cleaning.
Bottles flushing before filling with product.
PCA is used on:
Manufacturing Module.
Holding Reactor Module.
Sampling Area Module.
Weighing Area Module.
Filling Module.
Feeding Bottles Module.
Washing and Storage Module.
Laboratory Module.
CA supplied must be oil-free.
PCA station includes:
Flow monitoring.
Sterile filter 22μm, to convert regular CA to PCA.
Integrity test sockets.
Pressure regulation valve.
Pressure monitoring.
Pressure safety valve.
OPTIONAL: Other inert gases
Depending on the final configuration and the products manufactured, SAMPU systems can be easily adapted to include stations for other inert gases, such as N2 or CO2.
These gases can be used for:
Creating inert atmosphere inside bottles during filling process.
Creating inert atmosphere inside product tanks.
These gases can be used on:
Manufacturing Module.
Holding Reactor Module.
Sampling Area Module.
Weighing Area Module.
Filling Module.
Laboratory Module.
Inert gas station includes:
Flow monitoring.
Sterile filter 0,22 μm.
Integrity test sockets.
Pressure regulation valve.
Pressure monitoring.
Pressure safety valve.
Design and Manufacturing criteria
For all surfaces in contact with clean utilities (applies to pipes, tanks and instruments):
Made of inox 316L with Roughness < 0,8μm.
Pressure tested + Passivated.
Only tri-clamp or welded connections.
Orbital welding, with GMP standard documentation package.
Welding inspection with borescope and/or radiography.
For those elements that must be flexible (such as seals or membranes), PTFE approved by GMPs will be used.
All valves are of diaphragm type.
Clean 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.
HMI
Centralized HMI to monitor and control all the stations of Clean 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.
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.
