Quality and Compliance

EN ISO 14644

EN ISO 14644 compliance

Our clean room products are compliant with the European Standard EN ISO 14644 standards. This means if you use our Standard Group products, including Barrier Isolators and Pass Boxes, they will maintain the required air cleanliness in your clean room environment. Our pass-through boxes also do not interfere with the conditions in which that level of cleanliness has to be controlled and maintained.

GMP and GAMP

GMP and GAMP compliance

The strict GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufacturing Practice) guidelines of International and European Union standards require clean rooms to meet certain particle numbers both during operation and the manufacturing process. Standard Group products will not hold you back from meeting these GMP qualifying standards, even from GRADE 1 level.

PED

Pressure Equipment Directive

The Pressure Equipment Directive (PED) (2014/68/EU) applies to the design, manufacture and conformity assessment of stationary pressure equipment with a maximum allowable pressure greater than 0,5 bar.

PED is in operation across Europe and sets out the standards for the design and fabrication of pressure equipment ("pressure equipment" means steam boilers, pressure vessels, piping, safety valves and other components and assemblies subject to pressure loading). Mechanical Seals are excluded from PED in that in accordance with the European Sealing Association (ESA), it is accepted that pumps and the majority of equipment with a rotating shaft are exempt from the Pressure Equipment Directive.

Further to statements on the EU Machinery Directive (98/37/EC), it is apparent that mechanical seals do not fall within the definition of machinery. The Standard Group of Companies however elects to decide to comply within the scope of the Machinery Directive by;

• issuing a Declaration of Incorporation
• supplying the mechanical seal without a CE mark
• supplying appropriate instruction manuals
• maintaining systems for the compilation of Technical Files as appropriate.

PER

Pressure Equipment Regulations

Pressure Equipment Regulations (PER) has been implemented in the UK by the Pressure Equipment Regulations 1999 (SI 1999/2001). The Health and Safety Executive (HSE) and local authorities are responsible for enforcing PER. Equipment definitions include;

• Pressure equipment – vessels, piping, safety accessories and pressure accessories. Where applicable, includes elements attached to pressurised parts such as flanges, nozzles, couplings, supports, lifting lugs etc.
• Vessel - a housing designed and built to contain fluids under pressure. Includes its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
• Piping - piping components intended for the transport of fluids when connected together for integration into a pressure system. Includes a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate.
• Heat exchangers consisting of pipes for the purpose of cooling or heating air are considered as piping.
• Safety accessories - devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include devices for direct pressure limitation, such as safety valves and bursting discs etc, and limiting devices which either activate the means for correction or provide for shutdown or shutdown and lock out, such as pressure switches or temperature switches etc.
• Pressure accessories - devices with an operational function and having pressure-bearing housings.
• Assemblies - several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.