ISO/TC 209 launches new cleanroom standards and outreach projects, Roberta Burrows, David Ensor
Abstract, US-led outreach task team will foster promotion and education of the expanding body of ISO/TC 209 Standards. Keywords: ISO, TC 209, 14644, 14698, cleanroom, particle deposition rate, cleanroom consumables.
Standards update summary, John Neiger
HEPA versus ULPA: which filter should your biosafety cabinet use?, Bill Peters, Daniel Hillman
Abstract, This article sets out to explain the function and airflows of the most widely used Class II BSC (biosafety cabinet) in both the US and Europe. The two key standards for BSCs are NSF/ANSI 49 for the USA and EN 12469 for Europe. HEPA (High Efficiency Particulate Air) and ULPA (Ultra Low Penetration Air) air filters are described with reference to IEST RP- CC001 for the USA and EN 1822 for Europe. The article concludes that HEPA filters are perfectly adequate for BSCs whereas ULPA filters have a higher initial cost, a shorter working life and a much higher energy requirement.
Achieving contained (dust-free) milling, James Ellis
Abstract, Implementing a closed system for handling material with strict OEL/OEB requirements is becoming a growing challenge for pharmaceutical manufacturers. This article outlines the challenges and offers real-world solutions for achieving genuine contained milling. While there are numerous methods to achieve containment, this article will primarily focus on:
container-to-container milling,
in-line vacuum transfer,
milling inside an isolator.
Equipment Requirement Specification – a way to clarity?, Helen Hale
Abstract, The User Requirement Document (URS) for equipment is often used as a ‘catchall’, often full of irrelevant information for an equipment manufacturer. This paper introduces the idea of an Equipment Requirements Specification (ERS). Whilst the URS has been used for many years, it has often caused confusion, replication of ideas and standards, leaving the manufacturer to wade through, what is often a large and complex protocol, in the hope of identifying the specifications and data they need. It could be argued that the URS is an internal document therefore. There is another document that could be used for the external / manufacturer use, and that is an Equipment Requirements Specification protocol. Whilst this may contain much of the information in the URS, it is more honed to the equipment requirements and not the processing that will be carried out in the isolator, thereby reducing the initial developmental timescale.
News
Cherwell publishes in-depth guide to prepared culture media
Cleanroom Guangzhou Exhibition 2018 launches global campaign, and notches up early successes
CRC strengthens HVAC expertise with new appointment
BPS Crowthorne offers VPHP fumigation of equipment and facilities
Contec launches a new Compact Bucket System
Life-lines
Events and Training courses
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