Validations

Validation requires assurance through documented evidence to prove validation compliance with relevant regulatory requirements. SteriPack Contract Manufacturing has a successful track record of implementing a corrective validation approach. Whether you’re introducing a new product, transferring a line, or bringing an existing line, our expert validation team will provide you with up-to-date policies and procedures. SteriPack Contract Manufacturing offers Process Validation Services to the Medical Device and Pharmaceutical Industries globally.

Using proven processes, the SteriPack Group delivers comprehensive medical device validation and qualification activities to Customers for new equipment installations, manufacturing & packaging, sterilisation, computer system validations and stability studies.

The process of medical device validation plays an essential role in the medical device and pharmaceutical industries. The SteriPack Group understands the value of an accurate validation to a successful business and how the requirements imposed by the ISO, GMP and FDA are crucial to the whole manufacturing process.

Processes which should be validated:

  •  Sterilisation processes
  •  Clean room ambient conditions
  •  Aseptic filling processes
  •  Sterile packaging sealing processes
  •  Lyophilisation process
  •  Heat treating processes
  •  Plating processes
  •  Plastic injection moulding processes

Example of medical device validations offered by the SteriPack Group:

Medical device validation:

  •  EN ISO 13485
  •  FDA 21 CFR: Part 820

Sterile barrier systems validation:

  •  Guide 4 EU guidelines for good manufacturing practice, medicinal products and human and veterinary use
  •  GMP Polish Directive (Dz.U.Nr 126, poz.1381, z późn. zm)

Sterile barrier systems validation:

  •  EN ISO 11607-1
  •  EN ISO 11607-2

Sterilisation validation:

  •  EN ISO 11135
  •  EN ISO 11137

Injection moulding validation: 

  •  EN ISO 13485
  •  FDA 21 CFR: Part 820

Cleaning validation:

  •  EN ISO 15883
  •  ASTM F3127

Cleanroom validation (controlled environment):

  •  EN ISO 14644

Computerised systems validation: 

  •  ISO 13485
  •  GMP Annex 11
  •  FDA 21 CFR: Part 11
  •  GAMP 5

Using validation to ensure a robust process

By offering a medical device validation process that is above and beyond the requirements of Customers, good manufacturing practice and governing bodies, the SteriPack Group ensures Customers can model and adjust their final validation plans to meet any additional requests they might have. This extra step helps to ensure all processes are robust and can be repeated.

Design validation 

The approach to validating a new design or design revision needs to be clearly defined, documented and approved in advance of commencing a design activity. Validation should be performed on sample lots, prior to actual production runs.

The design validation should confirm that the product or process conforms to Customer requirements. The validation should include testing under expected operating conditions plus testing to the allowed limits of use.

Validation should cover all design outputs, based on potential risk. For example, if incorrect labels could post a risk to consumers, then the label manufacture and control process should be validated. If a risk assessment deems that verification would be an inadequate control or if verification is not to be performed due to cost considerations, then validation needs to be performed.

SteriPack's expertise:

cleanroom injection moulding, sterilisation, sterile barrier sealing validating.

medical devices injection moulding