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

4.3 Class III cabinets
4.3.1 General
4.3.1.1 A class III cabinet shall be a self-contained unit that includes at least a work space, prefilters, HEPA-filters and a blower for HEPA-filtered inlet and exhaust air. Provision shall be made to prevent the backward flow of contaminated air through the air-intake by the fitting of an inlet HEPA-filter that also provides a supply of sterile air to flush the interior and prevent contamination of the material being handled. If handling of organic toxins and non-corrosive volatile organic agents is required, an activated carbon filter shall also be included in the exhaust duct. Exhaust air shall be ducted to the outside atmosphere.

4.3.1.2 The cabinet shall be an independent operating unit and shall be independent of any other air- circulation system.

4.3.1.3 When a cabinet is tested in accordance with 6.1 .1 , it shall be gastight. At no location shall a gas leak in excess of 16,5 g per annum be detected.
4.3.1.4 The exhaust outlet may face in any direction, provided that it is readily accessible.
4.3.1.5 The work face of the work space shall include a viewing window and a sealed barrier that separates the operator from the work space. This barrier shall be fitted with gloves that are continuous with the barrier and the outer shell of the cabinet. The gloves shall enable the worker to handle materials inside the cabinet.
4.3.1. 6 All controls associated with the cabinet shall be operated from outside the cabinet.
4.3.1 .7 In order to contain potentially hazardous materials within the cabinet, the interior of the cabinet shall always remain under a negative pressure relative to the pressure in the work room/environment. A manometer with a range of -500 Pa to 500 Pa shall be mounted outside the cabinet to give a visual indication of the pressure of the interior negative pressure plenum.
4.3.1.8 Any contaminated zone under positive pressure shall be surrounded by zones maintained at negative pressure equal to that maintained in the cabinet work space.

4.3.1.9 There shall be specific access points in the exhaust duct for the measurement of the airflow rate.
4.3.1 . 1 Under no circumstances shall a class I cabinet be upgraded to comply with the requirements
of a class III cabinet.
4.3.2 Glove ports
Manipulation in the work space shall be carried out by means of glove ports which may also serve as transfer ports and for the attachment of transfer bags.
4.3.2.1 Glove port assembly
4.3.2.1.1 The glove port assembly shall be attached to the front panel of the cabinet either by means of suitable fasteners with sealing gaskets or shall be permanently welded to, riveted to or pressed from the front panel of the cabinet.

4.3.2.1.2 The glove port assembly shall comply with all the physical and chemical requirements for the outer shell of the cabinet, as specified in 3.3.1 .

4.3.2.1.3 The dimensions of the glove port assembly shall be such as to provide for the attachment of standard, commercially available beaded glove box gauntlets, without undue tension on the rims of the gloves. The manufacturer shall specify the glove cuff diameter or shape appropriate to the particular port size.

4.3.2.1.4 The outer side of the port ring shall have two grooves to accommodate the beaded cuff of the glove and of a secondary glove to permit changing gloves without compromising the seal.

4.3.2.1 .5 A bung that can be fitted Internally or externally to provide an efficient and absolute seal of the port shall be provided for each port.
4.3.2.2 Gloves (gauntlets)
4.3.2.2.1 The gloves shall fit either hand equally well and shall have beaded cuffs that are compatible with the diameter and shape of the glove ports.
NOTE - Gloves made from translucent material might be affected by DOP aerosol and other aerosols, and therefore
steps should be taken to prevent such gloves from coming Into contact with such aerosols when filter integrity tests are being conducted.
4.3.2.2.2 Gloves shall be made of translucent material in order to readily detect any damage to the glove.
4.3.2.2.3 The gloves shall be easily replaceable from outside the cabinet, by pushing the old glove to the inside of the cabinet and fitting a new glove while the blower is still running.
4.3.2.2.4 Gloves shall be attached to the ports in such a manner that they do not detach easily when in use. The means of attachment shall not compromise the integrity of the glove.
4.3.3 Filters
Both the inlet and the exhaust filters of a class III cabinet shall be HEPA-filters of a size appropriate for handling at least the specified airflow (see 4.3.4.2), and they shall be of size and specification given in 3.5.1.
4.3.4 Flow and distribution of air
4.3.4.1 When determined in accordance with 6.6.3.3.1 , the airflow velocity through the glove ports, when all gloves are detached, shall be at least 0,75 m/s.
4.3.4.2 When determined in accordance with 6.6.3.3.2, the airflow through the inlet filter, when the gloves are attached, shall be at least 3 m^3/min.
4.3.5 Work floor

The work floor shall be rigid, flat and constructed in one piece with radiused comers to facilitate cleaning and disinfection (see 3.4.2).
4.3.6. Transfer chamber
4.3.6.1 A transfer chamber may be fitted to the cabinet to permit the transfer of bulky items into the cabinet. If fitted, the transfer chamber shall be of a suitable size, with doors appropriate to the size of the items in question, and shall be fitted to the side of the cabinet.

4.3.6.2 The transfer chamber shall be a seamless gastight one-piece chamber with radius corners to facilitate cleaning and disinfection. When a transfer chamber fitted to the cabinet is tested in accordance with 6 1 the seams and joints of the doors and of the chamber shall show no sign of gas leakaqe AH materials used for the construction of the chamber shall comply with the requirements of 3.3.1. The chamber shall be fitted with in-line HEPA-filters and suitable valves to allow partial evacuation of the chamber, when required. 

Reference of the measure

Regulation 4.3 

Measure also domestic

Yes 

Products affected by the measure.

Description

Microbiological safety cabinets in class III 

Countries/Regions affected by the measure.

Description

All countries