68 Summary
Particularly in pharmaceutical and biotechnological applications in GMP conditions, safety cabinets and isolators typically enable the highest personnel and product protection. When combined with appropriate PPE and safe operating procedures such as limiting contact with personal items and work surfaces, cross-contamination risk is practically eliminated.
This level of protection becomes necessary when hazardous and sensitive material is handled, and it is of the utmost importance when the product has CMR properties. GMP Regulations require laminar airflows for safety cabinets of 0.45m/s ±20%.
The high downflow velocity for safety cabinets that conform with GMP is a challenge in weighing processes, especially when using analytical, micro and ultra-micro balances. Due to resulting vibrations and pressure fluctuations, higher minimum operating ranges in comparison to the theoretical minimum weight or even failures in calibration routines can result without appropriate counter measures.
Ways to minimise the negative effects on weighing performance are: • Use of solid worktops or special weighing worktops. • Separate weighing stones or metal plates decoupled from vibration. • Short cables to power supply and for interfaces. • Avoiding contact between cable wrappings and the balance. • Integration of peripheral devices or positioning them outside the cabinet.
Full integration of balances into the worktop is an interesting future goal for enhanced weighing and safety. This type of solution will require excellent cooperation between the manufacturers of balances and safety enclosures.
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Figure 3. Mettler-Toledo’s white paper describes 13 steps for safe, accurate weighing in safety cabinets or other enclosures.
This paper describes 13 steps for safe, accurate weighing in safety cabinets or other enclo- sures. Technical aspects of protective gear and enclosures are also covered, as are strategies to address the challenges inherent to weighing under such conditions to ensure high user safety, weighing accuracy, and product purity and quality.
Table of Contents 1. Introduction
2. Mandatory Personal Protective Equipment (PPE) 3. Guideline: 13 Steps to Safe Weighing 4. Technical Principles of Safety Cabinets and Isolators 5. Addressing Challenges in the Weighing Process 6. Summary 7. References
Staying Safe When Weighing Hazardous or Sensitive Materials
1. DIN 12980:2017-05. Laboratory installations - Safety cabinets and glove boxes for cytotoxic substances and other CMR drugs. Beuth Verlag, Berlin 2017. 2. EU GMP Annex 1: Manufacture of sterile medicinal products, revision Nov. 2008. 3. DIN EN 1822-1: High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking; German and English version. Beuth Verlag, Berlin. 4. ISO 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration. Beuth Verlag, Berlin. 5. EN 12469: 2000 Biotecholgy - Performance criteria for microbiological safety cabinets. Beuth Verlag, Berlin. 6. NSF International Standard/American National Standard: NSF/ANSI 49 -2014: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification. NSF International, Ann Arbor, Michigan, USA.
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www.labmate-online.com/article Laboratory Scale Kit for Safe Heating of Round Bottom Flasks
The DrySyn Scholar Kit from Asynt has been designed to meet, without compromise, the safety requirements required in academic laboratories for the heating and stirring of round bottom flasks, whilst maintaining ease of set up and use.
The DrySyn Scholar combines robustness, affordability and enhanced operator safety features making it the ultimate ‘student friendly’ heating block system.
Specifically designed for safety conscious teaching laboratories - the DrySyn Scholar kit enables the heating of single 100 mL and 250 mL round bottom flasks, without the mess or inherent safety hazards of a hot oil bath or heating mantle. Prominent lifting handles ensure moving even hot reaction blocks is easy, fast and safe. Options are available to further expand the use of the DrySyn Scholar base for reactions in 25 mL and 50 mL flasks.
Compatible with almost any magnetic hotplate stirrer, thanks to a set of adjustable feet, the low thermal mass design of the DrySyn Scholar delivers fast heating and low power consumption while maintaining accurate and precise temperature control.
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ilmt.co/PL/aAwr 51284pr@reply-direct.com
Ductless Fume Hoods Enhance Personnel Safety
The Purair Basic Series ductless fume hoods are compact, ideal for use in laboratory environments where space is limited or where only small volumes of harmful substances are handled. The Purair Advanced Series ductless fume hoods are available in 7 standard sizes in metal or polypropylene construction. This Series of high-efficiency products is designed to protect the user and the environment from hazardous vapours generated on the work surface.
Advanced ductless carbon filtration technology offers a safe, high performance alternative to conventional ducted fume hoods for a broad range of applications. Air Science ductless fume hoods isolate and trap chemical vapours to prevent ecological impact through release into the environment. Each filtration system is selected for its specific application. The Multiplex Filter broadens the range of applications. Carbon filters are available in more than 14 configurations for use with vapours or organic solvents, acids, mercury and formaldehyde. HEPA/ULPA filters can add to biological safety.
Air Science ductless fume hoods are self-contained and do not require venting to the outside. Many units are portable and may be moved from one location to the next with minimal downtime and without filter changes. Set-up, operation and filter maintenance are straightforward. The units are energy efficient as filtered air is returned to the room, so no demands are required of the facility HVAC capacity for make-up air. Facility ductwork, HVAC and construction costs are eliminated.
Cabinet airflow and face velocity protect users from incidental exposures to fumes. Selected models are self testing and electronic airflow monitoring assures continuous safety. An electronic gas sensor monitors carbon filter performance.
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INTERNATIONAL LABMATE - FEBRUARY 2020
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