Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B7: Product quality, safety or performance requirements 

Date when the measure came into force

02 April 2001 

Publication where the measure is specified

Government Notice R93 (Government Gazette 22014) Of 2 February 2001 

Regulation where the measure is specified

Compulsory Specification For Microbiological Safety Cabinets (Classes I, II And III) 

Country/Region applying the measure

South Africa 

The rationale of the measure

1.1 This specification covers requirements for the construction, fittings and pre-installation and post- installation performance of class I, class li and class III microbiological safety cabinets (also known as biological safety cabinets) intended to protect the operator and the environment from hazardous microbiological materials and (if so required by the customer or user or both), organic toxins and non-corrosive volatile organic agents.

NOTE - Microbiological safety cabinets are not intended to provide protection against corrosive chemical or radioactive materials.

1 .2 The specification does not cover the actual design of a safety cabinet and in no way restricts new design, provided that a microbiological safety cabinet of a new design complies with the requirements for materials, reliability, performance and safety given in this specification.

NOTE - Microbiological safety cabinets of class I, class II and class III should not be confused with laminar flow
clean workstations that usually discharge horizontally and vertically towards the operator and that do not provide
protection for an operator, but can even increase exposure to airborne hazards. 

Coded list of objectives

X: For purposes n.e.s. 

Description of the measure

3.5 Air filters
3.5.1 Recirculating, inlet and exhaust filters
3.5.1.1 Filter types
The installed HEPA-filters shall have a volumetric rate (airflow rate), specified by the manufacturer of the filter at least equal to the maximum rate necessary for the applicable part of the cabinet. Each HEPA-filter shall have been individually tested for filtration efficiency and filter integrity in accordance with an internationally acceptable standard at the manufacturer's designed volumetric rate.

3.6.1.2 Filter frame
All HEPA-filters shall have frames manufactured from metal that is corrosion resistant or protected against corrosion. Fluid or grease seals shall not be used.

3.5.1.3 Filter installation

3.5.1 .3.1 When the installed, recirculating, supply and exhaust HEPA-filters are tested in accordance with 6.4, there shall be no aerosol penetration exceeding 0,03 %.

3.5.1 .3.2 Gauges or manometers shall be fitted to monitor the pressure drop across the HEPA-filters. At least one gauge shall be provided.

3.5.1.3.3 The cabinet's filter aperture(s) shall match the filter frame exactly.

3.5.1.3.4 The filters shall not be fixed in place by means of adhesives or agents that solidify.

3.5.1.3.5 Petroleum jelly shall not be used on the seals.

3.5.1.3.6 The HEPA-filter gasket material shall be cellular, sheet or moulded rubber, or closed-cell expanded neoprene.

3.5.1.4 Access to filters and sampling ports

3.5.1.4.1 Access shall be provided to facilitate servicing and determination of the integrity of filters and seals.

3.5.1 .4.2 Where necessary, sampling ports for determining the 1 00 % datum concentration of the DOP challenge aerosol shall be provided for each HEPA-filter positive-pressure plenum, and the ports shall be connected by a tube of internal diameter at least 15 mm, to accessible positions in the negative- pressure plenum.

3.5.1.4.3 Each sampling port shall have a suitable, readily removable closure. Tubes and closures shall not penetrate the outer shell of the cabinet.

3.5.1. 5 Filter sealing plates

Sealing plates for both the inlet and the exhaust (where applicable) opening shall be provided to facilitate fumigation and disinfection. Where these plates are provided to seal the filters, they shall be fitted externally over the filters and shall provide an effective seal, to ensure that the filters are also decontaminated during fumigation.

3.5.1.6 Protection

A removable perforated guard shall be provided in the exhaust opening to protect the HEPA-f liter from mechanical damage and shall be so arranged that the discharge of air is not obstructed.

3.5.2 Prefilters

3.5.2.1 In orderto extend the life of the HEPA-filters, a prefilterthat is readily accessible shall be fitted upstream of the HEPA-filters.

3.5.2.2 When determined in accordance with 6.12, this prefilter shall have an average arrestance of 80 %.

3.5.2.3 The sample of the prefilter shall be submitted for testing in its unpleated state.

3.5.3 Activated carbon filter

3.5.3.1 When organic toxins and non-corrosive volatile organic agents are to be used, an activated carbon filter shall be installed downstream of the exhaust HEPA-fiiter.

3.5.3.2 The carbon filter shall be readily accessible for easy servicing, maintenance and replacement (see 3.3.4). A notice clearly stating the type of absorbence filter fitted and the date of installation or service shall be fixed to the front of the cabinet or control panel.

3.5.3.3 When use is made of carbon filters, the air in the cabinet shall be exhausted to the outside atmosphere through an exhaust duct the discharge end of which shall be above ground level, at least 3 m clear of any building air-intake or window that can open, and away from pedestrian traffic. 

Reference of the measure

Regulation 3.5 

Measure also domestic

Yes 

Products affected by the measure.

Description

Air filters for microbiological safety cabinets (Classes I, II And III) 

Countries/Regions affected by the measure.

Description

All countries