All HIGHTECH Extraction Systems are PED-certified (Pressure Equipment Directive — 2014/68/UE) and CE-marked as required by the latest regulations. In the USA, our systems are UL-certified and cUL for Canada. Pressure equipment is ASME-certified. The certifying body is Apave International.
Hazard Analysis Critical Control Points (HACCP)
The HACCP system was developed to ensure the safety of food for US astronauts nearly 30 years ago. It identifies any hazards that must be prevented, eliminated or reduced. HACCP system is internationally accepted as the system of choice for food safety management. It is a preventative approach to food safety based on the following principles:
- Identify the critical control points (CCPs) at the steps at which control is essential
- Establish critical limits at CCPs
- Establish procedures to monitor the CCPs
- Establish corrective actions to be taken if a CCP is not under control
- Establish procedures to verify whether the above procedures are working effectively
- Establish documents and records to demonstrate the effective application of the above measure
Good Manufacturing Practice (GMP)
GMP is a production and testing practice that helps to ensure a quality product. GMP guidelines give us a guidance for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.
It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. The term “manufacturing” is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, re-labeling, quality control, release, storage and distribution of APIs and related controls.
The GAMP5 guidelines relate to the regulated company and their good manufacturing practices. The responsibility for full compliance with relevant standards ultimately stops there. However, in GAMP5 greater importance has been placed on supplier leverage — that is, the supplier of a product or service should be aware of the guidelines and adhere to them. This way regulated companies can use the supplier’s documentation, testing, verification and quality plan to prove compliance with regulatory authorities.
The valves are certified in accordance with ASME B31.3. Piping is accompanied by a certificate of casting and stress-test certification. High-pressure vessels are individually PED-certified and CE-tested (test pressure P x 1.41). Safety valves are PED-certified. Institute non-destructive testing. All fittings are accompanied by a certificate of conformity. The measuring instruments are PED-certified.