Quality system

 Aerosol dispenser, gas cartridge or the fuel cell cartridge fillers and component manufacturers 

shall
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  
cartridges;
 
(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 
authority.
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.
 

Aerosol dispensers

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
rejected.

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
rejected.

Leak testing gas cartridges and fuel cell cartridges

 
Prior to filling and sealing, the filler shall ensure that the closures (if any), and the 
associated   sealing
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 
mass
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
6.2.6.3.1 and 6.2.6.3.2, 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".
4                                                                                                   
                                                                                  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).
 

6.3

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 4.1.4.1.

General

The requirements of this Chapter apply to packagings intended for the carriage of infectious
substances of Category A.

Requirements for packagings

The requirements for packagings in this section are based on packagings, as specified in 6.1.4,
currently used. In order to take into account progress in science and technology, there is no objection
to the use of packagings having specifications different from those in this Chapter provided that they
are equally effective, acceptable to the competent authority and able successfully to withstand the tests
described in 6.3.5. Methods of testing other than those described in ADR are acceptable provided they
are equivalent, and are recognized by the competent authority.

Packagings shall be manufactured and tested under a quality assurance programme which satisfies the
competent authority in order to ensure that each packaging meets the requirements of this Chapter.
NOTE: ISO 16106:2006 "Packaging – Transport packages for dangerous goods – Dangerous
goods packagings, intermediate bulk containers (IBCs) and large packagings – Guidelines for the
application of ISO 9001" provides acceptable guidance on procedures which may be followed.
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