A Statistical Approach in the Analysis of Geometrical Product Specification during the Cold Tube Drawing Process

Cold tube drawing provides higher accuracy compared to hot approaches. The process can be used to reduce the dimensions of tubes, and depending on the reduction size, the wall thickness of these may be subject to changes. In the process, any form of variability provoked by external factors is highly sensitive, given that the resulting tubes are often the final step in tube production. This paper focused on the evaluation of the influence of pre-tube factors on key variables after the drawing process, i.e., the final roundness, outer diameter, and wall thickness of the tubes. For these purposes, a factorial design with fixed factors was implemented. It was also a goal to investigate if the single-pass type of drawing would guarantee good statistical results potentially leading to significant time and financial reductions. The measurements were executed in the machine ZEISS CenterMax. The statistical analysis took place on Minitab 19. The results prove that most factors, and their interactions, significantly impacted the response variables, leading the authors to understand that a single-pass approach would not properly work under the conditions defined for the experimentation. These results also allow for reflection on the causes and necessary measures related to lubrication, technological heritage, and quality that would impact the results themselves.

Recommendations for the Contents of the “Glycan Profile” Part of a Product Specification File

“Glycan Profile” is a necessary part of manufacturers’ product specification files for monoclonal antibody active ingredients or final products and erythropoietin active ingredients. The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

Recommendations for the Contents of the “Peptide Mapping” Part of a Product Specification File

‘Identification. Peptide mapping’ is a necessary part of manufacturers’ product specification files for therapeutic proteins (active ingredients and final products of monoclonal antibodies, filgrastims, erythropoietins). The expert of the Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of the Russian Federation provides recommendations for a step-by-step presentation of the test procedure, which will allow applicants to align product specification files for Russian- and foreign-produced medicinal products, help experts to minimise or eliminate the need to request additional information from applicants, and will contribute to timely batch release of medicinal products.

Can ISO GPS and ASME Tolerancing Systems Define the Same Functional Requirements?

Geometrical tolerances are defined in the ISO Geometrical Product Specification system that is used worldwide, but on the other hand, the ASME Y14.5 standard is used in American companies to define how far actual parts may be away from their nominal geometry. This paper aimed to investigate whether specifications defining acceptable geometrical deviations in one system can be transformed to specifications in the other system. Twelve selected cases are discussed in the paper. Particularly, two cases of size tolerance, three cases of form tolerances, one case of orientation tolerance, four cases of position tolerance (including position tolerance with MMR for the pattern of five holes) and, finally, two cases of surface profile tolerance (unequally disposed tolerance zone and dynamic profile tolerance). The issue is not only in the several different symbols and a set of different defaults, but also in the different meanings and different application contexts of some symbols that have the same graphical form. The answer to the question raised in the paper title is yes for the majority of indications specified according to ASME Y14.5 when new tools from the 2017 edition of ISO 1101 are applied.

PROPOSING A SPECIFICATION STRUCTURE FOR COMPLEX PRODUCTS IN MODEL-BASED SYSTEMS ENGINEERING (MBSE)

This research work presents a methodological support for the specification of complex products. This is achieved by developing a specification structure in a MBSE environment. The new method draws on success factors of complex product specification, principles of MBSE and the explanatory model of PGE – Product Generation Engineering. For evaluation, the method is applied within a student development project. A high applicability and the realization of novel synergies for coping with continuously increasing product complexity is demonstrated.

Critical Analysis of Scalability of Reconfigurable Manufacturing Systems

Due to the rapidly increasing industrial competition in the globe, it has now become fundamental of engineering firms to implement fundamental industrial approaches, which promptly and reliably focusses on sudden transformation of the design of engineered products. Emergent strategies, which might allow forms to cope up with the quickly transforming changes of product specification is centered on Reconfigurable Manufacturing Systems (RMSs). This research contribution discusses the significance of the presently available scalable Manufacturing Systems (MSs) that allows engineering firms to meet the demands of the market quickly. RMSs have to be designed on the outset of the futuristic scalability to allow its cost-effective and prompt expansion according to the demands of the globe. As such, this research contribution provides the principles to given manufacturing systems’ design to enhance scalability.

Biodiversity and Safety Assessment of Half-Century Preserved Natural Starter Cultures for Pecorino Romano PDO Cheese

The use of biodiverse autochthonous natural starter cultures to produce typical and PDO cheeses contributes to establishing a link between products and territory of production, which commercial starters, constituted by few species and strains, are not able to. The purpose of this work was the assessment of biodiversity, at strain level, and safety of natural scotta-innesto cultures whose use is mandatory for the Pecorino Romano PDO cheese manufacturing, according to its product specification. The biodiversity of three scotta-innesto, collected in the 1960s and preserved in lyophilised form, was assessed by molecular biotyping using both PFGE and (GTG)5 rep-PCR profiling on 209 isolates belonging to Streptococcus thermophilus (30), Lactobacillus delbrueckii subsp. lactis (72), Enterococcus faecium (87), and Limosilactobacillus reuteri (20), revealing high biodiversity, at the strain level, in the cultures. The cultures’ safety was proved through a new approach assessing phenotypic and molecular antibiotic resistance of the cultures in toto, instead of single strains, while the safety of Enterococcus faecium isolates was investigated according to EFSA guidelines. The use of natural biodiverse cultures for the production of microbial starters for typical and PDO cheeses, such as Pecorino Romano, could be an opportunity for recovering the cheese microbiota biodiversity lost during years of commercial starters use.