The ‘FEA alternative method’ is an integrated Quality Assurance and testing package which aims to ensure substandard aerosols are identified and rejected before they enter transport and distribution.
The ‘FEA alternative’ method has the following key elements:
Quality Assurance procedures are used by the container maker to ensure that only containers that are pressure stable and leak-tight are supplied to the Filler. Central to this is that all empty aerosol containers are leak and pressure tested to a pressure equal to or in excess of the maximum expected in the filled aerosols at 55°C.
Quality Assurance procedures are used by the valve supplier to ensure that only valves that have all their components in place and that will be pressure stable and leak tight once crimped on a container are supplied to the Filler.
Quality Assurance procedures are used during handling and filling to check that only high quality aerosols are produced. Procedures include:
Checks on the crimping equipment settings to maintain the correct valve crimp dimensions.
An in-line check-weigher system to ensure overfilled aerosols are rejected.
A micro-leak detector on the filling line to test the valve and valve crimp of all filled aerosols for leaks.
Filled aerosols rejected by check weigher or micro-leak detector may be over filled and unstable or else leaking. It is therefore important to have safety systems in place that are able to handle these aerosols. A number of methods are available to reject aerosols from the filling line; BAMA recommends soft reject systems that avoid further damage to the aerosols. The aerosol reject systems and procedures and the storage areas for rejected aerosols should be subjected to a DSEAR4 risk assessment and if necessary the areas classified as Zone 1. This is because this part of the filling line, especially the reject bins, may contain a flammable atmosphere; further advice may be obtained from The BAMA Standard.
Verification of the ‘Alternative Method’
BAMA recommends that companies wishing to use an ‘alternative method’ to the hot water bath test follow the system developed by FEA. Because it has already been proven to comply with the requirements of ADR2017, the verification exercise would therefore be limited to ensuring that the company has implemented and is adhering to a system that complies with the ‘FEA Alternative Method’.
BAMA recommends that verification be done by an approved independent third party audit of the whole system. In time, the DFT may decide to accept internal audits as evidence of compliance, but this is not likely until experience has been gathered from operating ‘alternative methods’.