Pharmaceutical Industry

Quality Assurances

Pharmaceutical products are subject to constant quality controls and testing. With Spectac you can rest assured that the equipment we create for your pharma manufacturing facilities will meet the highest standards.

Quality Standards

Our company is registered and certified as ISO Occupational Health and Safety 18001:2007, ISO Quality Management Standard 9001:2008, ISO Environmental Management Standard 14001:2004 and we also operate to BSI and TUV quality and safety standards. All our pharmaceutical vessels are PED certified and designed to ASME / PD 5500 standards. TUV Rheinland (NoBo 0035) is the notified body to certify our manufactured vessels and provide certification of conformity. TUV inspects and verifies that the vessels conform as per the design and PED requirements. Spectac International is also Royal & Sun Alliance certified.

TUV

TUV is a German abbreviation for Technischer Überwachungsverein which in English translates to Technical Inspection Association. TUV Rheinland is a German company and are one of the world’s leading testing service providers. In accordance with international standards TUV certify management systems, train people in numerous professions and test technical systems and products across a wide range of industries. As independent experts, a TUV certification generates trust in both processes and products by confirming that the defined criteria and safety aspects have been met. This certification is widely seen across Europe and shows that manufacturers who achieve a TUV certification are committed to producing quality products with consistent specifications. TUV Rheinland (NoBo 0035) is the notified body to certify Spectac International’s manufactured vessels and provide certification of conformity. TUV inspects and verifies that the vessels conform as per design and PED requirements.

PED

PED stands for Pressure Equipment Directive, a piece of European legislation in place since 2002. It is aimed at removing the technical barriers to trade concerning to the supply of pressure equipment, to ensure common standards of safety in all pressure equipment sold within the EU. At Spectac this is monitored by the standards body BSI. PED applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar gauge. The Directive has a wide range of Conformity Assessment Modules that define what the documentation required and to what extent a notified body should be involved. For PED, the risk of the product is based upon three factors: the state of the contained fluid; the stored energy & the hazards associated with the fluid. In Europe, all equipment that contains fluids at a pressure greater than 0.5 bar must comply with the PED and bear the CE mark. All Spectac International manufactured pharmaceutical vessels are PED certified and designed to ASME / PD 5500 standards.