Journal contents list

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Issue 20: October 2014

Main features

The application of the ventilation equations to cleanrooms -

Part 2: Decay of contamination

W Whyte, S Ward, WM Whyte and T Eaton

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Abstract

This article is the second of a three-part series that investigates the application of the ventilation equations to designing and testing cleanrooms. This part is concerned with the decay equation. The recovery test, described in ISO 14644-3 (2005) is discussed, and improvements recommended. The application of the decay equation to the 'clean up' requirement given in the EU GGMP (2008) is also discussed. Finally, a method is considered that calculates the time needed for airborne contamination in cleanroom areas to decay to acceptable concentrations.

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The Chemical influence on ISO 14644 standards

Dick Gibbons

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Abstract

This article attempts to explain the rationale behind the addition of chemical classification standards to the 14644 family of cleanroom standards. The author is a Chartered Mechanic de motor industry, micro-electronics, disc drives and start-up ventures across Europe. It concludes with an assessment of the three new standards and an indication on further progression. Names of the companies involved would be controversial and are therefore excluded.

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A history of isolator and containment technology

Part 3: Non-flexible film isolators including RABS

Doug Thorogood

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Abstract

This third paper on the history of isolators describes the development and use of non-flexible film isolators including restricted access barrier systems (RABS). By non-flexible is meant that type of unit that has a metal or a rigid plastic structure. These are referred to as conventional isolators.

Many of these models have been designed to enclose various types of filling machines for processing vials, ampoules, cartridges or syringes and are the descendants of glove boxes or safety cabinets for aseptic processing.

RABS appear to have been largely devoted to aseptic filling of various forms of vial and syringe or filling products for terminal sterilisation and are dependent on unidirectional airflow as in conventional clean rooms.

Other such isolator models have been used for handling, processing and compounding pharmaceutically active materials and for enclosing small tanks, washing utilities, analytical instruments, etc. Some of the flexible film units such as sterility testing or for hospital pharmacy use have also been replaced by rigid versions. One addition to mention is the preparation and compounding of radio-active products.

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"Up there with penicillin"

Professor Sir John Charnley's total hip replacement surgery and his collaboration with Hugh Howorth on ultra clean theatres

Amanda Parkin

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Abstract

This article looks at the influence Professor Sir John Charnley has had on orthopaedics on the occasion of the 50th Anniversary of the development of his ground-breaking hip replacement surgical technique at Wrightington Hospital in Lancashire, England. It describes the work Charley did in his biomechanical laboratory at Wrightington to improve, not only the implants, but also the surgical process of replacement. It goes on to describe his association with Hugh Howorth of Howorth Air Engineering (now Howorth Air Technology) which led to the early 'greenhouse' operating theatre and the total body exhaust operating gown. The article ends with a brief description of the very latest ultra clean ventilation canopy from Howorth Air Technology.

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Applying spectrophotometric monitoring to risk assessments in biopharmaceutical cleanrooms

Tim Sandle

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Abstract

Spectrophotometric particle counters are the main item of cleanroom monitoring technology to have emerged in recent years. The counters can differentiate inert particles from 'biologic' particles (where biologic may indicate a microorganism). This article outlines a summary of a study that examined the application of spectrophotometric particle counters to the risk assessment of a cleanroom that underwent deactivation and reinstatement cleaning. The study demonstrates how establishing a particle and biologic particle baseline can provide useful information to compare the environmental condition of a cleanroom pre- and post-maintenance shutdown.

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Advertorial

Rapid transfer port systems - a comparative study by Getinge-La Calhène

Cyril Mounier and Chloé Guilmet

Regulatory reflections

Guidelines raise standards for contamination control

James Tucker

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