The pharmaceutical industry develops and manufactures pharmaceutical substances (drugs) for use as medications.
As drugs generally enter the human body, either by swallowing, intravenously, intramuscular or subcutaneous, there is a high risk potential for human harm. Therefore the industry is tightly controlled and is subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy and marketing of the drugs.
All decisions on equipment, processes and setup can increase the potential risk of immediate or eventual human harm in addition to influencing both the efficiency of research and efficiency of production. A compromise in either quality or quantity is unacceptable in the Pharmaceutical sector therefore manufacturing plants need to align themselves with trusted suppliers with the appropriate technical expertise and experience.
The Standard Group is a trusted supplier to many national and international pharmaceutical clients, having extensively supplied the sector for many years. We have supplied the largest aseptic isolator system in India, custom designed and manufactured for a prestigious client in Chennai (shown above).
CE Marked Products
Our products are CE conforming for use in the European Union, when specified. This CE declaration ensures that the Standard Group products meet the high-standard requirements of the European community’s product directives. It not only provides a legal base for the Standard group to be put on the market, but also sets strict and essential requirements in quality, health, safety and environmental protection.
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 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.
Pressure Equipment Directive
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.
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.
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