End-to-end qualification of ready-to-use (RTU) product containers in packaging suitable for No-Touch Transfer (NTT) into Grade A filling zones

No-Touch Transfer (NTT) of pre-sterilised ready-to-use (RTU) containers is an alternative methodology that follows Good Manufacturing Practice (GMP) and Quality Risk Management (QRM) principles. NTT de-bagging ejects contents from secondary bag packaging without direct contact with contents or exposure to an environment that is a lower grade than the zone being entered. The pre-sterilised containers and sterile barriers offer assured sterility at manufacture and are qualified to remain sterile through the supply chain and the stepwise NTT de-bagging process. This eliminates the requirement for in-process material disinfection steps for transfer into Grade A environments. The present article focuses on design qualification of pre-sterilised RTU container packaging, including definition of sterile barriers together with bioburden study data through the supply chain and simulated NTT. It completes a series of EJPPS articles to support peer-reviewed references on NTT. Together, these articles can be defined as end-to-end qualification of the NTT process, demonstrating a high level of assurance that sterility is maintained from manufacture to point of use. Key Words: Aseptic processing, Design qualification, Good Manufacturing Practice (GMP), Life cycle, No-Touch Transfer (NTT), Pharmaceutical packaging, Pre-sterilised containers, Qualification, Quality by Design (QbD), Quality Risk Management (QRM), Ready-to-use (RTU), Supply chain

Assessment of environmental risks of space activities as a determinant of global security

The paper investigates environmental risks of space activities in ensuring the concept of Clean Space as an integral component of global security. It has been proven that man-made debris in orbital space reached catastrophic proportions which calls upon immediate changes with the purpose of sustainable development of space activities. The work incorporates an elaborated classification of environmental risks that occur in the process of space activities, divided into four groups: by the source of risk, by type of orbit, by cause and effect and by the possibility of influence. It has been determined that countries to have generated the most space debris objects are Russia (the USSR), USA and China. Ukrainian national legislation in the sphere of space activities is currently at the stage of harmonization with international space agencies. Numerous issues remain insufficiently substantiated: improvement of the Technical Regulations for space activities, Procedures of liability insurance for damage inflicted to the space object, since the respective insurance contract must be one of the documents mandatory for fulfilling international obligations of the state with regard to its accountability for any type of national space activities. It has been established that apart from the Kessler effect there also exists a temporality effect – the effect of ”lengthened” time combined with the effect of its acceleration (singularity) – accelerated development of situational changes. This affects the catastrophic state of space debris cluttering in Earth’s orbit since the launch of the first artificial satellite. The paper examines a particular range of risks in accordance with two phases of the technological lifespan of space systems – ‘Operation’ & ‘Utilization’. It is stipulated by the fact that namely in these phases there exists the highest probability of occurrence of major risks of “influence”. Prospects of further research consist in the development of the system for assessment of risks of influence at all phases of the technological lifespan of space systems: ‘Mission analysis/needs definition’; ‘Feasibility’; ‘Preliminary design’; ‘Detailed design’; ‘Qualification & Production’; ‘Operation’; ‘Utilization’.

Degradation of PVDF-Coated Fabrics after Engineering Applications: Correlations between Surface Microstructure, Physical Properties, and Mechanical Properties Based on Statistical Analysis

Material degradation has marked impact on the long-term properties and service life of membrane structures. This study is aimed at assessing and understanding the deterioration in visual aspect, surface microstructure, and mechanical properties of a polyvinylidene fluoride (PVDF) polymer after engineering applications. Three groups of PVDF-coated fabrics were removed from different membrane structures in China, which have been used for 15, 16, and 19 years, respectively. Firstly, spectrocolorimetry tests were carried out to determine the evolution of chromaticity and lightness. Other methods such as contact angle and thickness measurements were used to characterize the physical properties. Then, surface morphology was observed by using scanning electron microscope (SEM) technology. Moreover, a series of uniaxial tensile tests and tearing tests were performed to obtain the mechanical indicators including uniaxial tensile strength, strain at break, tearing strength, and uniaxial elastic modulus. In order to further study the degradation mechanism, infrared spectroscopy was used to characterize the molecular structure of aged fabrics. Finally, Principal Component Analysis (PCA) provided a comprehensive description of correlations between surface microstructure, physical properties, and mechanical properties. This paper offers a further understanding of the design, qualification, and durability evaluation of membrane structures.

Electrically Heated Trace Flowline on Ærfugl Project - A journey from Product Qualification to Offshore Campaign

The Ærfugl field is close to the existing Skarv development located in Norwegian Sea, making it a tie-back opportunity. The hydrate management and operational savings were major drivers for the subsea system design requiring the use of an electrically heated trace flowline (EHTF). The scope of this paper is to present how the EHTF technology has been further developed, qualified and industrialized during the execution of the Ærfugl project. It will also illustrate how a unique collaborative model between an Operator, an SPS Contractor and an EPCI Contractor contributed to the delivery of the first heated Pipe in Pipe system on a sizable project. Starting from a conceptual technology selection to the project delivery, numerous qualifications were performed to validate the EHTFsystem design and ease its industrialization. The development of a new technology starts from the component design through system qualification up to the installation phase. It is of prime importance that all the different phases of the system life cycle are equally considered, as being interdependent. By using this holistic design approach right from the start of the qualification phase, the final product eventually meets all the requirements, from the component specification to the system performance. The collaborative model in place on the Ærfugl project allowed the efficient integration of the Operator at each different step of the design, qualification and industrialization process resulting in delivery schedule savings when compared to a conventional project delivery approach. Several important development activities took place during the Ærfugl project and the holistic design approach backed by robust system engineering processes enabled a smooth and efficient workflow supporting the onshore fabrication and offshore installation readiness activities. Several fabrication challenges were overcome during the project to safely deliver the EHTF solution with a continuous focus on quality and this paper will also cover the most relevant ones. Following the Ærfugl project execution, the EHTF technology, supported by a unique collaborative model with the operator, is now fully qualified, and deployed offshore based on robust and reliable manufacturing and installation methods.