New validation package which ensures cost-effective validation of temperature-controlled facilities

Validation of temperature-controlled facilities and equipment may be seen as a time-consuming task for experts. However, it is necessary according to current requirements – and this means that new ways of thinking must be applied by maintaining the high quality, which ensures that the product has been manufactured and stored under the right conditions and that the company is in compliance with current guidelines.

AlfaNordic has developed a validation package which is based on best in class workflows and automation of document generation and can reduce the time spent on preparation and execution. Below we will go through the most important challenges in qualification/validation of this type of facilities/equipment.

Our most important experience

  • The requirements for given equipment may be difficult to test.
  • The regulatory requirements are higher/more demanding than expected by the authorities.
  • Synergies in simultaneous validation of equipment are not utilised across the organisation. (Matrix qualification).
  • Methods, protocols and work routines that are not optimised according to the complexity of the equipment extend the time spent by the validation responsible person and in QA for e.g. review and approval.

Avoid requirements that cannot be tested via a risk analysis

We see requirements which cannot be tested in practice; for example a requirement that the material in a refrigerator consists of a particular material. This may be a good requirement for the delivery from the supplier, but it is not a suitable requirement for testing. Therefore it is important to make a risk analysis and plan the qualification through that. In this way you can ensure that only the necessary and sensible requirements are repeated in the qualification documentation.

Higher requirements than requested by authorities

An example could be to set the max / min limits inappropriately in relation to the products which will be stored in the room/equipment. A well-conducted risk analysis can ensure that only relevant requirements are included and get the same attention as high-risk issues which naturally should be tested and documented.

Matrix qualification can ensure synergies across the organisation in identical equipment and give financial benefits

Far from all equipment is specially designed, and often some synergy may be found (matrix qualification), and in this way an optimised testing phase may be ensured. The equipment may be placed in different rooms and across the organisation. This makes an optimisation complex and requires teamwork across departments and budgets. The time spent for testing 4 identical pieces of equipment simultaneously is significantly less and may mean great savings. However, the equipment still needs to be processed individually. With the correct documentation method you as a company achieve reduced validation time and shutdown and in turn a financial gain.

Non-uniform methods, requirements and routines across departments may hinder a cost-effective process.

In some cases validation is handled differently across different departments. This is not necessarily because the departments do not agree with each other, but it is due to less focus on optimisation across the organisation. By optimising to the same systematic method, many companies will achieve standardisation and a cost-effective validation process of temperature-controlled areas.

With AlfaNordic's validation package you as a company can optimise your validation process

AlfaNordic has developed a validation package, which partly contains consultancy in relation to validation of temperature-controlled facilities and partly takes product risks and the expectations of the authorities for the extent of the validation as its starting point.

The significant benefits of the validation package include:

  • The time for preparation and review of documentation is cut in half.
  • AlfaNordic has a close cooperation with a DANAK accredited supplier of measuring equipment.

The validation package contains:

  • Risk assessment
  • Specification of requirements
  • Traceability matrix
  • Protocol
  • Test plans
  • Report

The validation package is adjusted to the specific equipment and product. On the basis of this, the test and report may be carried out simply and rationally – either with own employees or with AlfaNordic as a sparring partner and/or AlfaNordic can carry it out.

Read more about AlfaNordic's validation concept at https://alfanordic.com/validering-af-temperaturkontrolleret-udstyr-og-rum/ and receive feedback on how you can get off to a good start.

Facts

AlfaNordic has developed a validation package which is based on ‘best in class’ workflows and automation of document generation and can reduce the time spent on preparation and execution.

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