During the audit we will identify:
We will compare the length of the dead leg to its diameter, take into account direction of cleaning solution.
We will assess cleanability of dismountable couplings and weld quality.
We will verify whether there is no product retained in closed position of the valve or whether a product line is hygienically separated from the cleaning solution line.
Not fully drainable installation
We will inspect inside of installation (with 5 meters long endoscope) and document deviations.
We will search for surface defects e.g. cracks, fissures, which could adversely affect cleanability.
We will verify whether there is no product retained in bypasses.
For dismantled equipment, we will indicate areas where cleaning solution has a poor access to.
Rough product contact surfaces
We will measure Ra / Rz roughness in few points of installation with calibrated roughness tester.
Not cleaned line components
We will search for line components which are not cleaned at all.
The audit process:
Stage 1. Documentation review (prior to on site audit)
When shared by the client:
• Information on type of the products produced, cleaning (and disinfection) methods used
• Information on construction materials used
• Line P&ID
Aim: To understand hygiene level required; to adjust audit scope
Stage 2. On site audit (1 small size line* per 1 day)
Inspection should take place when the line has been cleaned and is ready for production.
• The line is inspected ‘equipment by equipment’ / ‘meter by meter’ – both from outside
and inside (with endoscope or after equipment disassembly, basic equipment disassembly
is to be ensured by the client).
• During inspection, surface roughness will be tested with calibrated roughness tester
in 5 – 10 points of installation
(measured points will be indicated by the client or chosen by the auditor).
• For proper process understanding and risk evaluation of identified deviations, it is advised
that during the inspection, a discussion should take place about both the technical,
and process solutions employed (e.g. about possible line configurations
during production and cleaning processes).
• An audit can be carried out in any production plant in Europe (audit and report in English).
* Normally – up to approx. 50m of piping with valves/measurement devices etc., up to 3 product tanks.
Stage 3. Reporting (within 21 days after the audit)
Report will be prepared in English. It contains:
• Photos of identified deviations (from outside and inside of the line – from endoscope
or after equipment disassembly).
• Description of deviation and its localization.
• Basic risk evaluation and proposed corrective actions (if possible to determine based on information
collected during audit).