Hot water bath test
The temperature of the water bath and the duration of the test shall be such that the internal pressure
reaches that which would be reached at 55 °C (50 °C if the liquid phase does not exceed 95% of the
capacity of the aerosol dispenser, gas cartridge or the fuel cell cartridge at 50 °C). If the contents are
sensitive to heat or if the aerosol dispensers, gas cartridges or the fuel cell cartridges are made of
plastics material which softens at this test temperature, the temperature of the bath shall be set at
between 20 °C and 30 °C but, in addition, one aerosol dispenser, gas cartridge or the fuel cell cartridge
in 2 000 shall be tested at the higher temperature.
No leakage or permanent deformation of an aerosol dispenser, gas cartridge or the fuel cell cartridge
may occur, except that a plastic aerosol dispenser, gas cartridge or the fuel cell cartridge may be
deformed through softening provided that it does not leak.
With the approval of the competent authority alternative methods that provide an equivalent level of
safety may be used provided that the requirements of 126.96.36.199.2.1 and, as appropriate, 188.8.131.52.2.2 or
184.108.40.206.2.3 are met.
Aerosol dispenser, gas cartridge or the fuel cell cartridge fillers and component manufacturers
have a quality system. The quality system shall implement procedures to ensure that all aerosol
dispensers, gas cartridges or the fuel cell cartridges that leak or that are deformed are rejected
and not offered for transport.
The quality system shall include:
(a) A description of the organizational structure and responsibilities;
(b) The relevant inspection and test, quality control, quality assurance, and process operation
instructions that will be used;
(c) Quality records, such as inspection reports, test data, calibration data and certificates;
(d) Management reviews to ensure the effective operation of the quality system;
(e) A process for control of documents and their revision;
(f) A means for control of non-conforming aerosol dispensers, gas cartridges or the fuel cell
(g) Training programmes and qualification procedures for relevant personnel; and
(h) Procedures to ensure that there is no damage to the final product.
An initial audit and periodic audits shall be conducted to the satisfaction of the competent
These audits shall ensure the approved system is and remains adequate and efficient. Any proposed
ved system shall be notified to the competent authority in advance.
Pressure and leak testing of aerosol dispensers before filling
Each empty aerosol dispenser shall be subjected to a pressure equal to or in excess of the maximum
expected in the filled aerosol dispensers at 55 °C (50 °C if the liquid phase does not exceed 95% of
the capacity of the receptacle at 50 °C). This shall be at least two-thirds of the design pressure of the
aerosol dispenser. If any aerosol dispenser shows evidence of leakage at a rate equal to or greater than
3.3 × 10-2 mbar.l.s-1 at the test pressure, distortion or other defect, it shall be rejected.
Testing of the aerosol dispensers after filling
Prior to filling the filler shall ensure that the crimping equipment is set appropriately and the specified
propellant is used.
Each filled aerosol dispenser shall be weighed and leak tested. The leak detection equipment shall be
sufficiently sensitive to detect at least a leak rate of 2.0 × 10-3 mbar.l.s-1 at 20 °C.
Any filled aerosol dispenser that shows evidence of leakage, deformation or excessive mass shall be
Gas cartridges and fuel cell cartridges
Pressure testing of gas cartridges and fuel cell cartridges
Each gas cartridge or fuel cell cartridge shall be subjected to a test pressure equal to or in excess of the
maximum expected in the filled receptacle at 55 °C (50 °C if the liquid phase does not exceed 95% of
the capacity of the receptacle at 50 °C). This test pressure shall be that specified for the gas cartridge
or fuel cell cartridge and shall not be less than two thirds the design pressure of the gas cartridge or
fuel cell cartridge. If any gas cartridge or fuel cell cartridge shows evidence of leakage at a rate equal
to or greater than 3.3 × 10-2 mbar.l.s-1 at the test pressure or distortion or any other defect, it shall be
Leak testing gas cartridges and fuel cell cartridges
Prior to filling and sealing, the filler shall ensure that the closures (if any), and the
equipment are closed appropriately and the specified gas is used.
Each filled gas cartridge or fuel cell cartridge shall be checked for the correct mass of gas and
shall be leak tested. The leak detection equipment shall be sufficiently sensitive to detect at
least a leak rate of 2.0 × 10-3 mbar.l.s-1 at 20 °C.
Any gas cartridge or fuel cell cartridge that has gas masses not in conformity with the declared
limits or shows evidence of leakage or deformation, shall be rejected.
With the approval of the competent authority, aerosols and receptacles, small, are not subject to
220.127.116.11.1 and 18.104.22.168.2, if they are required to be sterile but may be adversely affected by water
bath testing, provided:
(a) They contain a non-flammable gas and either
(i) contain other substances that are constituent parts of pharmaceutical products for
medical, veterinary or similar purposes;
(ii) contain other substances used in the production process for pharmaceutical products; or
(iii) are used in medical, veterinary or similar applications;
(b) An equivalent level of safety is achieved by the manufacturer's use of alternative methods for
leak detection and pressure resistance, such as helium detection and water bathing a statistical
sample of at least 1 in 2000 from each production batch; and
(c) For pharmaceutical products according to (a) (i) and (iii) above, they are manufactured
under the authority of a national health administration. If required by the competent authority,
the principles of Good Manufacturing Practice (GMP) established by the World Health Organization
(WHO)3 shall be followed.
Reference to standards
The requirements of this section are deemed to be met if the following standards are complied with:
- for aerosol dispensers (UN No. 1950 aerosols): Annex to Council Directive 75/324/EEC4 as amended
and applicable at the date of manufacture;
- for UN No. 2037, small receptacles containing gas (gas cartridges) containing UN No. 1965,
hydrocarbon gas mixture n.o.s, liquefied: EN 417:2012 Non-refillable metallic gas cartridges for
liquefied petroleum gases, with or without a valve, for use with portable appliances -
Construction, inspection, testing and marking;
3 WHO Publication: "Quality assurance of pharmaceuticals. A compendium of guidelines and related
materials. Volume 2: Good manufacturing practices and inspection".
f the laws of the
Member States relating
ished in the Official Journal of the European Communities No. L 147 of 9.06.1975.
- for UN No. 2037 small receptacles containing gas (gas cartridges) containing non-toxic, nonflammable
compressed or liquefied gases: EN 16509:2014 Transportable gas cylinders - Nonrefillable,
small transportable, steel cylinders of capacities up to and including 120 ml
containing compressed or liquefied gases (compact cylinders) – Design, construction, filling
and testing (excluding clause 9).
REQUIREMENTS FOR THE CONSTRUCTION AND TESTING OF PACKAGINGS FOR CLASS 6.2 INFECTIOUS SUBSTANCES OF CATEGORY A
NOTE: The requirements of this Chapter don't apply to packagings used for the carriage of Class 6.2
substances according to packing instruction P621 of 22.214.171.124.