scholarly journals A global disinfectant standard for cleanrooms: Presenting a harmonised approach

2021 ◽  
Author(s):  
Tim Sandle
Keyword(s):  
Control Strategy ◽  
International Standards ◽  
Bacterial Spores ◽  
Contamination Control ◽  
International Standard ◽  
Log Reduction ◽  
Logarithmic Reduction ◽  
Disinfectant Efficacy

Disinfectant efficacy testing is an essential part of a facility contamination control strategy. Pharmaceutical and healthcare products facilities must know that the products they are using can achieve effective levels of microbial kill across a range of surface types. The problem faced by microbiologists and production managers is that the various national and international standards use different methodologies. In addition, these standards and methods have not been written specifically for cleanrooms and the microbial test panels and logarithmic reduction expectations are not considered suitable. In order to develop an international standard suitable for all pharmaceutical facility cleanrooms, Ecolab has developed the Validex™ method, which is independently assessed in this paper. This method involves using 2 cm diameter disks, to target a 3 log reduction for vegetative bacteria in 5 minutes; and a 2 log reduction for fungi and bacterial spores in 10 minutes. The key criteria and rationale for selection, along with the methodology, are presented in this paper.

scholarly journals Assessing the impact of libraries – the role of ISO 16439

2018 ◽  
Vol 119 (1/2) ◽  
pp. 87-93 ◽  
Author(s):  
Claire Creaser
Keyword(s):  
Design Methodology ◽  
International Standards ◽  
Content Type ◽  
International Standard ◽  
The World ◽  
The Difference ◽  
Library Impact ◽  
The Impact

Purpose Library impact and how to evaluate it has been debated for a number of years. While the activity – the busy-ness – of the library is now routinely measured and described, the difference the library makes is less tangible and harder to measure. Libraries in all sectors and worldwide are grappling with this issue, and the purpose of this paper is to summarise international standards available to support them. Design/methodology/approach The first international standard concerning library impact, ISO 16439 Information and documentation – methods and procedures for assessing the impact of libraries, was published in 2014 after several years in development. Findings The standard describes a range of methods for assessing library impact which have been used across the world in a variety of libraries in all sectors. Originality/value This paper summarises the key methods described in the standard, and gives references for further reading.

A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer
Keyword(s):  
Control Strategy ◽  
Control Strategies ◽  
Pharmaceutical Manufacturing ◽  
Production Facility ◽  
Vaccine Production ◽  
Contamination Control

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

Introduction

2020 ◽  
pp. 1-14
Author(s):  
Lucia Quaglia
Keyword(s):  
Political Economy ◽  
International Relations ◽  
International Political Economy ◽  
Standard Setting ◽  
International Standards ◽  
International Regime ◽  
International Regulation ◽  
International Standard ◽  
Derivatives Markets ◽  
Regulatory Reforms

This chapter outlines the theoretical and empirical puzzles that inform the book, its objectives, overall argument, and structure. This research sets out to explain the post-crisis international regulation of derivatives markets. In particular, it addresses three interconnected questions. What factors drove international standard-setting concerning derivatives post-crisis? Why did international regime complexity emerge? How was it managed and with what outcomes? The focus of this volume is on international standards, not the domestic implementation of these standards, or other domestic regulatory reforms concerning derivatives. This chapter also outlines the book’s theoretical and empirical contributions to the international relations literature on regime complexity and the international political economy literature on the regulation of finance.

scholarly journals Reference Reagents for Prostate-specific Antigen (PSA): Establishment of the First International Standards for Free PSA and PSA (90:10)

2000 ◽  
Vol 46 (9) ◽  
pp. 1310-1317 ◽  
Author(s):  
Brian Rafferty ◽  
Peter Rigsby ◽  
Matthew Rose ◽  
Thomas Stamey ◽  
Rose Gaines Das
Keyword(s):  
Confidence Interval ◽  
Prostate Specific Antigen ◽  
Recombinant Dna ◽  
Collaborative Study ◽  
Specific Antigen ◽  
International Standards ◽  
Serum Samples ◽  
International Standard ◽  
Free Psa ◽  
Total Psa

Abstract Background: Prostate-specific antigen (PSA) measurements in serum by immunoassay are widely used in the screening, diagnosis, and monitoring of patients with prostate cancer although the lack of common reference reagents has led in the past to wide differences in estimates. We report here the results of a WHO international collaborative study in which two preparations of PSA representative of the main immunoreactive components in serum, free PSA and PSA 90:10, and a preparation of recombinant DNA-derived PSA were assessed as potential standards for the calibration of diagnostic immunoassays for PSA. Methods: Coded vials of the candidate materials and serum preparations containing PSA in the clinically important range were provided to the 10 laboratories in the study, and participants were asked to perform PSA assays currently in use in their laboratories. Data from 89 immunoassays by 26 different method-laboratory combinations were contributed to the study and analyzed centrally at the National Institute for Biological Standards and Control. Results: Potency estimates of the preparations relative to the in-house calibrators were in good agreement with the target value of 1 μg of total PSA/vial, the preparation of free PSA giving 1.10 μg/vial (95% confidence interval, 0.99–1.21 μg/vial) and PSA 90:10, 1.11 μg/vial (95% confidence interval, 1.04–1.18 μg/vial). No immunoreactivity was detected in ampoules containing the recombinant material. Use of a common standard of PSA 90:10 significantly reduced the between-laboratory geometric coefficients of variation for serum samples included in the study and gave a much narrower range of potency estimates. Conclusions: The preparation of free PSA was established by WHO as the First International Standard for PSA (free) with an assigned content of 1 μg of total PSA per vial. In addition, the preparation of bound PSA was established as the First International Standard for PSA (90:10) with an assigned content of 1 μg of total PSA per vial.

International Standards for Boilers and Pressure Vessels

2009 ◽  
Author(s):  
Stuart Cameron ◽  
Richard Gene Feigel
Keyword(s):  
World Trade ◽  
Pressure Vessels ◽  
International Standards ◽  
International Standard ◽  
Realistic Approach ◽  
Lengthy Process ◽  
A Performance

This paper outlines the need for a single comprehensive International Standard for boilers and pressure vessels but also recognizes that the development of such a standard will be a lengthy process. The development of a performance based standard is seen as the best realistic approach to facilitating world trade and progress on this is described.

scholarly journals THE PARTICIPATION OF LABORATORIES IN INTERLABORATORY COMPARISON TESTS. BASIC REQUIREMENTS. PRACTICAL IMPLEMENTATION OF REQUIREMENTS. PROSPECTS

2017 ◽  
pp. 11-13
Author(s):  
A.A. Kramarenko ◽  
V.V. Kirpichnik
Keyword(s):  
Interlaboratory Comparison ◽  
Accreditation Body ◽  
International Standards ◽  
National Standards ◽  
Practical Implementation ◽  
Accreditation System ◽  
International Standard ◽  
National Accreditation ◽  
Testing Laboratories

The topical issues of participation of laboratories in interlaboratory comparison tests, the requirements of the international standards ISO, requirements of transnational and national standards ISO, the national accreditation body are considered. The progress on the revision of the international standard ISO/IEC 17025:2005 and the order of the transition to the updated version of 2017 are described. The information about changes in the approach of the national accreditation body to organizations of interlaboratory comparison tests (ICT) is given. The immediate prospects for the russian providers of interlaboratory comparison tests (ICT) and testing laboratories accredited in the national accreditation system are defined.

scholarly journals Experience of the organization in Ukraine of the system of training of specialists for prosthetic industry according to international standards

New Collegium ◽  
2021 ◽  
Vol 1 (103) ◽  
pp. 19-28
Author(s):  
V. Semenets ◽  
A. Salieieva ◽  
O. Avrunin ◽  
V. Grishchenko ◽  
I. Karpenko ◽  
...  
Keyword(s):  
Training Program ◽  
Social Protection ◽  
International Standards ◽  
Modern World ◽  
Practical Training ◽  
Production Operation ◽  
Highly Qualified ◽  
International Standard ◽  
Provision Of Services ◽  
Research Institute

At the present stage, the problem of training for related industries in the system of production, operation of products and provision of services is especially relevant. To a large extent, this is typical of medicine and related industries that are engaged in the production and operation of biotechnological devices and systems, electronic medical devices and the provision of rehabilitation services in health and social protection systems. Training of specialists in the field of prosthetics and orthoses for the manufacture of means for the rehabilitation of patients with musculoskeletal disorders. The aim of the work is to highlight the experience of the main stages of training of modern specialists for the prosthetic industry according to international standards. To do this, it is necessary to consider the main approaches to the formation of curricula, the organization of practical training and the scientific component of the training program for prosthetics and orthoses. From 2001 to 2012 according with cooperation program between KNURE and the Ukrainian Research Institute of Prosthetics 5 groups of bachelors and specialists with a total of 72 graduates underwent training under this program, 4 groups with a total of 65 graduates underwent retraining. In order to implement the project "Creation of prosthetic and orthopedic education in Ukraine", based on an international agreement between the Ukrainian Research Institute of Prosthetics, Kharkiv National University of Radio Electronics and the School of Rehabilitation Sciences (NS) began in January 2018 a training program for teachers-trainers for prosthetics and orthoses according to the educational program "Orthopedic Technologies and Engineering", developed in accordance with the international standard ISPO category II. The main stages of cooperation, practical and scientific parts for master's training in the specialty "Orthopedic Technologies and Engineering" in the specialty 163 – "Biomedical Engineering" are considered. In accordance with the international standard ISPO, a program for training specialists in prosthetics and orthoses according to the scientific plan "Orthopedic Technologies and Engineering" has been created and started to operate. The perspective of the work is the development of modern educational content for the training of highly qualified specialists of different levels of education in "Orthopedic Technologies and Engineering" in accordance with modern world standards.

scholarly journals Insight into the New EU GMP Annex 1

2021 ◽  
Author(s):  
Frank Panofen, ◽  
Daniele Pandolfi ◽  
Maurizio Della Pietra ◽  
Anna Campanella ◽  
Giulia Artalli ◽  
...  
Keyword(s):  
Risk Management ◽  
Control Strategy ◽  
Successful Implementation ◽  
Contamination Control ◽  
Analysis Process ◽  
Process Understanding ◽  
Management Concepts ◽  
Clear Differentiation ◽  
Insight Into ◽  
The Eu

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. The contamination control strategy and its dependence on trend analysis, process understanding, thorough investigation, and a commitment to progress is now an essential activity referenced multiple times through the document. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are critical to successful implementation of system controls.

Reverse engineering legal professional privilege in a globalising world – the Australian case

2020 ◽  
Vol 23 (3) ◽  
pp. 677-690
Author(s):  
Doron Goldbarsht
Keyword(s):  
Quantitative Research ◽  
Task Force ◽  
International Standards ◽  
Quantitative Aspect ◽  
International Governance ◽  
Content Type ◽  
International Standard ◽  
Australian Case ◽  
Legal Professional

Purpose This paper aims to explore the ways in which the international standards in the field of anti-money laundering (AML) and counter-terrorist financing (CTF) have reshaped regulatory regimes in a globalised world. Design/methodology/approach This paper deconstructs the origins and development of international standards in the field of AML and CTF dealing with longstanding legal professional privilege. This paper adopts both qualitative and quantitative research methodologies. The qualitative aspect comprises a literature review of sources, including scholarly works, Financial Action Task Force (FATF) recommendations, reports and domestic laws. The quantitative aspect analyses a unique and comprehensive table reproduced below, that indicates Australia’s compliance with all the FATF recommendations over more than a decade with full alternation to FATF’s revisions of its recommendations. Findings This paper demonstrates that an understanding of the influence of the FATF norms can shed light on the departure from regular lawmaking processes and emerging forms of international governance. The conclusion suggests that tranche II is coming and Australia will amend it in domestic regime to comply with the international standard, applying the AML/CTF regime to the legal profession and thus interfering with legal professional privilege. The question is not if but when. Originality/value This paper fills the gaps in the existing literature by contemplating the future of legal professional privilege globally and in Australia, which provides a case study of a regime that does not yet comply fully with AML and CTF international standard. This approach differs significantly from that of other literature in the field, which deals comprehensively with the theoretical foundations of legal professional privilege, as well as its practicalities and limitations, without considering the influence of the international non-binding norms.

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