Operational Qualification of the Individualisation of Protective Clothing Design Based on the 3D Scanning Technique

The object of the publication is to present the validation process stage (operational qualification) of developed assumptions for customised clothing manufactured in industrial conditions. 12 special clothes were made and adjusted to the individual dimensions of firefighters’ silhouettes obtained in the 3D scanning process as well as 12 special clothes adjusted to selected size subgroups after the 3D scanning process from the same identified group of 12 firefighters. Two batches of clothes having undergone the installation qualification were submitted for testing in real conditions (operational qualification). Then, on the basis of data collected from the ongoing functional tests, a batch of six sets of individualised special clothing for the Fire Service was produced in industrial conditions (changing the manufacturer and model of the clothing). A positive result of validation (operational qualification) of this batch of clothing in functional tests conducted in real conditions will allow its introduction to industry through training in production plants and procedures of individualisation of advanced protective clothing design for people working in environments with a high degree of risk to health and life. The individualisation of protective clothing design, through a better fit of the size of the clothing to the body of the user, will significantly affect the comfort of use, ergonomics of the clothing, and the safety of the user.

Modelling the marine ecosystem of IBI European waters for CMEMS operational applications

<p>As part of the Copernicus Marine Environment Monitoring Service (CMEMS), a physical-biogeochemical coupled model system has been developed to monitor and forecast the ocean dynamics and marine ecosystem of the European waters. The model domain, called Iberia-Biscay-Ireland (IBI), covers the North-East Atlantic Ocean from the Canary Islands to Iceland, including the North Sea and the Western Mediterranean. Based on NEMO-PISCES with a horizontal resolution of 1/36°, the CMEMS IBI coupled model has provided 7-day weekly ocean forecasts for CMEMS since April 2018. But prior to its operational launch, a pre-operational qualification simulation (2010-2016) has allowed assessing the model's capacity to reproduce the main biogeochemical and ecosystem features of the IBI area. <br>The objective is to evaluate the capacity of the coupled model to reproduce the spatial distribution and seasonal dynamics of the main biogeochemical variables, using this 7-year qualification simulation. The model results are compared with available satellite estimates as well as in situ observations, with a focus on BGC-Argo floats. <br>The evaluation confirms that this model system can be a useful tool to better understand the current state and changes in the marine biogeochemistry of European waters and can also provide key variables for developing indicators to monitor the health of marine ecosystems. </p>

Modelling the marine ecosystem of Iberia–Biscay–Ireland (IBI) European waters for CMEMS operational applications

As part of the Copernicus Marine Environment Monitoring Service (CMEMS), a physical–biogeochemical coupled model system has been developed to monitor and forecast the ocean dynamics and marine ecosystem of the European waters and more specifically on the Iberia–Biscay–Ireland (IBI) area. The CMEMS IBI coupled model covers the north-east Atlantic Ocean from the Canary Islands to Iceland, including the North Sea and the western Mediterranean, with a NEMO-PISCES 1∕36∘ model application. The coupled system has been providing 7 d weekly ocean forecasts for CMEMS since April 2018. Prior to its operational launch, a pre-operational qualification simulation (2010–2016) has allowed assessing the model's capacity to reproduce the main biogeochemical and ecosystem features of the IBI area. The objective of this paper is then to describe the consistency and skill assessment of the PISCES biogeochemical model using this 7-year qualification simulation. The model results are compared with available satellite estimates as well as in situ observations (ICES, EMODnet and BGC-Argo). The simulation successfully reproduces the spatial distribution and seasonal cycles of oxygen, nutrients, chlorophyll a and net primary production, and confirms that PISCES is suitable at such a resolution and can be used for operational analysis and forecast applications. This model system can be a useful tool to better understand the current state and changes in the marine biogeochemistry of European waters and can also provide key variables for developing indicators to monitor the health of marine ecosystems. These indicators may be of interest to scientists, policy makers, environmental agencies and the general public.

Double entry method for the verification of data a chromatography data system receives

The importance of software validation increases since the need for high usability and suitability of software applications grows. In order to reduce costs and manage risk factors, more and more recommendations and rules have been established. In the field of pharmacy the vendors of so-called chromatography data systems (CDSs) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last few years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that wishes to create, edit and sign electronic information instead of printing them on paper. Subsection CFR 21 part 11.10(h) explains how to perform an input check for manual user entries as well as for data that will be collected from an external device. In this article we present an approach performing the double entry method on data provided by the hardware instrument in order to investigate possible influences on the raw data by the handling CDS. A software tool has been written which allows us to communicate with a high-performance liquid chromatography (HPLC) detector and acquire data from it. The communication is completely independent of a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as with the double entry method for the data verification. For the second CDS we checked whether it would be applicable after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software.

Validation and Various Qualifications in HVAC System - A Review from Pharmaceutical Quality Assurance Prospect

The safety of personnel and efficacy of the material including raw ingredients, in-process goods and finished products as well as machineries in the pharmaceutical industry is majorly impacted by the air ventilation quality within the industry. HVAC system stands for Heating, Ventilation and Air Conditioning system, which ensures the optimum quality of air environment as directed by regulatory authorities. The performance of HVAC system is ascertained by conducting validation of this system within specified duration. Validation of HVAC system is achieved at three levels such as installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ); Which is subject to provide documented evidence about the accuracy of results produced by it. The validation of HVAC system involves systemized and assembled documents of its functional specifications such as design drawings, plans, and specifications; followed by validation master plan involving testing, adjusting, and balancing (TAB); and finally, the startup reports. The parameters analyzed are air flow velocity, air flow pattern, air changes per hour, filter leak test, particle count, viable monitoring, filter integrity test, pressure difference, recovery test for temperature and humidity, temperature and humidity uniformity, and fresh air determination.

AN OVERVIEW OF ANALYTICAL INSTRUMENT QUALIFICATION WITH REFERENCE OF PHARMACEUTICAL INDUSTRY

In the most general sense, validation refers to a process that consists of at least four distinct components or steps: software, instruments, methods or procedures, and system suitability The system, the software, and the method must all be validated, and system suitability is used to keep the process in check. But while the overall process is called validation, some of the steps also are referred to by that same term, as well as other steps such as qualification and verification. Analytical instruments are used for a specific analysis. So regular performance verifications are made to ensure that the instrument to be used is suitable for its intended application. All equipments used in the production of products shall be properly Validated and Calibrated to demonstrate that it is suitable for its intended purpose. The current equipment qualification programs and procedures used within the pharmaceutical industry are based on regulatory requirements, voluntary standards, vendor practices, and industry practices. The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and the way they interpret the often vague requirements. The process for instrument qualification follows the 4Qs model approach. It include design qualification (DQ), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ). The goal of any regulated laboratory is to provide reliable and valid data suitable for its intended purpose. Analysts use validated methods, system suitability tests, and in-process quality control checks to ensure that the data they acquire are reliable and that there are specific guidance and procedures available to ensure compliance. Keywords: Qualification, FDA, Instruments, Validation, Calibration, Documentation

ESGE-ESGENA technical specification for process validation and routine testing of endoscope reprocessing in washer-disinfectors according to EN ISO 15883, parts 1, 4, and ISO/TS 15883-5

Statements 1 Prerequisites. The clinical service provider should obtain confirmation from the endoscope washer-disinfector (EWD) manufacturer that all endoscopes intended to be used can be reprocessed in the EWD. 2 Installation qualification. This can be performed by different parties but national guidelines should define who has the responsibilities, taking into account legal requirements. 3 Operational qualification. This should include parametric tests to verify that the EWD is working according to its specifications. 4 Performance qualification. Testing of cleaning performance, microbiological testing of routinely used endoscopes, and the quality of the final rinse water should be considered in all local guidelines. The extent of these tests depends on local requirements. According to the results of type testing performed during EWD development, other parameters can be tested if local regulatory authorities accept this. Chemical residues on endoscope surfaces should be searched for, if acceptable test methods are available. 5 Routine inspections. National guidelines should consider both technical and performance criteria. Individual risk analyses performed in the validation and requalification processes are helpful for defining appropriate test frequencies for routine inspections.