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Build standards

The machine will be produced to our Grade 1 engineering standard for pharmaceutical aseptic processing machinery requiring a Grade A environment.

The equipment will be built to support working to current Good Manufacturing Practice (European Medicines Agency/Food and Drug Administration/Medicines and Healthcare products Regulatory Agency) regulations and guidelines, with careful consideration given to specific machine design requirements.

 

Construction materials and finish

Typical process area designfeatures features
  • First-air design principle design wherever practicable
  • Seals to segregate the process area from technical spaces
  • Hygienic fittings at the process level and above
  • Minimal cables
  • Minimal crevices
  • Sterilisable contact parts, fitted without contacting critical surfaces and whilst protecting first air

Typical equipment construction outside the process area
  • Aluminium plates and extruded aluminium structural frame. Frame may be anodised or clad in stainless steel 304 panel
  • Further stainless steel panels/covers with minimal gaps, suitable for a Grade C cleanroom environment
  • Electrical controls, PLC and pneumatic valves are integrated into the frame of the machine and/or external stainless-steel cabinets.

Product contact parts

Manufactured from the following, unless otherwise stated or agreed:

  • Stainless Steel AISI 316 and 316L
  • PTFE, Polyetheretherketone (PEEK)
  • Silicone (hopper)
  • Glass
  • Titanium

Non-product contact Parts

Manufactured from product contact suitable materials and

  • Stainless Steel AISI 304
  • EPDM, Polyethylene, Polypropylene, Polyurethane
  • Silicone

Unless otherwise stated or agreed

Surface finish

Stainless steel product contact parts: 0.4 to 0.8µm Ra.

Non-product contact stainless steel parts typically 0.4 to 1.2 µm Ra.

Material certification

For direct product contact parts only. Certificates will be supplied as follows:

  • Metals – 3.1 Mill certificate and Supplier traceability.
  • Polymers – Standard supplier Certificate of Conformity

 

Power and services: Clean room requirements

Floor requirements for weighing

The system relies on a high-precision weigh cell for its operation. Accordingly, the floor on which the machine is located must be solid, (not a suspended floor), ground level and suitable for precision weighing. It is assumed that the machine will be located in a temperature-controlled environment, typically 20°C nominal.

Electrical supply

Single 13A single-phase 230 VAC supply /

32A three-phase 415 VAC supply

Mains supply will enter at the back of the controls cabinet, via a flexible cable, nominally 5 metres long

Compressed air

6 bar, oil-free, clean compressed air supply

Flow rate required to be confirmed at Design Qualification

Machine extraction

Not required / Required and

supplied with machine / utilises client in-house extract system

Process vacuum

Not required / Required and

supplied with machine / utilises client in-house extract system

Machine documentation

Documentation
  • Operational instructions (including troubleshooting)
  • Electrical and pneumatic schematics
  • Assembly drawings
  • Recommended maintenance schedule and procedures
  • Spare parts list
  • Calibration methods and certificates for all critical devices (shall be traceable to UKAS or equivalent national standard)
  • Material certification
  • Polishing certificate for product contact surfaces, where appropriate
  • CE certification

Machine conformance

CE Conformance

The essential health and safety requirements of the following EC Directives apply:

  • Machinery Directive 2006/42/EC
  • EMC Directive 2014/30/EC
  • Pressure Equipment Directive 2014/68/EU
  • Supply of Machinery (Safety) Regulations 2011 SI 2008/1597
  • Electromagnetic Compatibility Regulations 2016 SI 2016/1091
  • Pressure Equipment (Safety) Regulations 2016 SI 2016/1105

UKCA Conformance

The essential health and safety requirements of the following UK Statutory Instruments apply: