The Equipment Qualification Testing Framework: Model Driven Development for Design and Model-Based Testing for Verification

Computer control systems (CCS) are an important for operation and maintenance of safety- critical infrastructures. A challenge in such systems implementation is certification and licensing against national and international regulatory requirements. Environmental tests are applied to check that equipment of the CCS can withstand the rigors of harsh environments, for example high and low temperature and humidity, water drops and dust, seismic vibration and acceleration, electromagnetic interference, radiation, etc. It can happen that environmental tests emphasis is methods, level and types of environmental impacts, but there is a question about functions which shall perform a system under test before, during and after test impact application. Equipment Qualification Testing Framework is proposed. The requirements to system operation under test is described in view of a model. Model Driven Development methodology is applied for design and Model-based Testing methodology is applied for verification

High Flux Reactor Continued Safe Operation: Time Limited Ageing Analyses

The High Flux Reactor (HFR) is a multipurpose nuclear reactor located in Petten, the Netherlands. With its 45 MWth it is one of the most powerful and versatile research reactors in the world. Its main roles are material irradiation and medical isotopes production. The output of the reactor in terms of medical isotopes is important at a global level (60% of European demand). Every day in the Netherlands alone 30.000 patients are treated using isotopes produced in the HFR. The importance of the HFR dates back in time. The HFR has been in service since 1961. Due to the long life (58 years to date) of the reactor an efficient integrated ageing management program (AMP) is envisaged as it is foreseen that the HFR will continue to operate for a prolonged period of time. The development of the AMP has begun in 2018 (CSO project) and will be completed in view of the IAEA CSO mission. The HFR is the second reactor in the world to undergo this type of IAEA review and one of the objectives of this project is to set a state of the art when it comes to research reactors long term operation. The CSO project foresees four major sections: scoping and screening, development and improvement of plant programs, (re) validation of time limited ageing analyses (TLAAs) and realization of the ageing management program. In this paper the focus will lie on the TLAAs. The applicable TLAAs were scoped starting from the IGALLs TLAAs list. The TLAAs relevant for the HFR are: TLAA fatigue, TLAA reactor vessel, TLAA leak before break, TLAA manufacturing flaws TLAA beryllium and TLAA equipment qualification. The latter was developed in the framework of the equipment qualification plant program and does not figure as an independent TLAA in the CSO project. For each TLAA the principal problematics will be highlighted and the possible solutions illustrated.

A Review on Life Cycle Management Approach on Asset Qualification

All equipment’s used in the production of products shall be properly Validated, Qualified and Calibrated to demonstrate that it is suitable for its intended purpose. Qualification is an important aspect of the pharmaceutical quality system. When the equipment is properly qualified, verified and maintained, there is the possibility of Consistent performance of the equipment. A well designed qualification program saves valuable time and cost. Qualification is called a cyclic process because it is a never ending process. Appropriate documentation of the qualification program is very important as lack of the documented evidence does not give any meaning to qualification (Not documented it means not done). The current programs and procedures of equipment qualification used within any pharmaceutical and bioscience industry are based on ‘regulatory requirements’, ‘voluntary standards’, ‘vendor practices’, and ‘industry practices’. The output is considerable variation in the way any pharmaceutical and biotechnological companies approach for the laboratory equipment. The lifecycle management approach of equipment qualification covers entire life cycle for the specification, design, manufacturing, installation, commissioning, qualification (4Qs Model DQ, IQ, OQ, PQ), operation & maintenance of equipment in a risk based life cycle management approach. The goal of any regulated pharmaceutical and bioscience company is to provide reliable and valid data suitable for its intended purpose. Main goal of equipment qualification is to form the basis for written procedures for production and process control which are designed to assure that the drug products have the SISPQ (Safety, Identity, Strength, Purity and Quality) Keywords: Validation, Calibration, Life cycle management approach, Qualification (4Qs Model- DQ, IQ, OQ & PQ), SISPQ (Safety, Identity, Strength, Purity and Quality)

A Review on qualification of the tablet compression machine

Validation is the art of designing andpracticing the designed steps alongside with the documentation. Validation is one of themostimportant steps in maintaining &achievingthe quality of the final product group after batch. The qualification of the equipment and systems are planning to carry out the tests and record the tests. We cannot be manufacturing the product, without an equipment. If the equipment is validated, we can ensure that our product is of the top-quality. Validation of the equipment is known as Qualification. To making different kinds of dosage forms, various equipment’s are used. Here, this article concentrates on the equipment qualification for theTablet compression machine. It gives in detail, qualification steps of the equipment, which is used for the manufacturing process through wet granulation. Qualification, an ideal step for equipment validation, is the action undertaken to demonstrate the intended use and performance of the utilities and equipment.The individual steps of qualification such as design, installation, operational and performance qualification, were done in order to qualify the equipment. Blueprint of equipment validation was also included and the tablets were tested for physical parameters such asappearance, punch Shape, punch diameter, upper punch, lower punch, hardness, weight variation, friability, and thickness.