Risk minimization through validation
Bringing medical products to market safely and in compliance with regulations!
Our experienced validation experts offer practical support on the path to safe product approval.
Maximum safety through validation!
Manufacturers of medical devices are obliged to minimize the risks posed by their products . Through validation, manufacturers prove that their processes have been developed safely and robustly, but also that they will deliver reliable results over the entire duration of the product life cycle.
The validation of processes in medical technology is regulated by various bodies and standards (such as FDA, 510k, ISO, GMP, cGMP, MDSAP, ...).
We are experts in the development of medical tubing and injection molded plastic parts and also support you in the validation of injection molding processes as well as downstream processes such as assembly .
Process validation - making safety measurable!
We are experienced specialists in the processing of plastics into hoses and injection-molded parts for use in medical technology. As part of our project management, we also offer process validation - making safety measurable.
Your advantages at a glance
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Validation is always carried out when product properties cannot be verified non-destructively on the finished product.
The breaking strength of an injection molded part, for example, cannot be verified as the part would have to be destroyed for this. However, the manufacturing process as such can be validated as reproducible.
It is therefore not enough to simply implement processes that produce products in some way. Rather, it must be proven that the products are produced exactly as described in advance at all times.
Find out more in the interview with Robert Schreiner, process developer and validation engineer at Novoplast Schlauchtechnik.
IQ, OQ, PQ - from plan to report
A validation is intended to show that a process, test procedure or system meets the previously specified requirements in a reproducible manner in practical use. The validation master plan (VMP) is the overarching qualification document in which all qualification and validation activities are described in advance. The process requiring validation itself usually runs through the required qualification in three steps:
- IQ Installation Qualification
- OQ Operational Qualification (functional qualification)
- PQ Performance Qualification
Finally, the validation report contains the assessment Validation passed or Validation failed.
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White paper "Validation of plastic components - fast, compliant & (audit)safe placing on the market"
Our white paper provides an overview of the relevant specifications and common standards for the validation of plastic components in medical technology, explains key terms and shows what practical support experienced and reliable partners can provide for the validation of plastic components.
Validation - yes or no?
Validation is one of the fundamental building blocks of quality management in medical technology. However, specific instructions or a "one-size-fits-all" recipe are often sought in vain. This is because validation is process-dependent and is determined by a large number of process-related variables. Therefore, use our practical decision matrix and check in advance whether validation is necessary or not.
The Specialists for precision Injection Moulding
Founded in 1974, Fleima-Plastic is located in Wald-Michelbach in the Odenwald region and has been part of the Masterflex Group since 2004. The company produces high-quality injection molded parts and assembled modules made of plastics, primarily for the medical technology, cosmetics and food technology sectors. The modern plant produces, assembles and finishes injection-molded components - also using multi-component technology.
Fleima-Plastic also has many years of experience in the construction of precision injection moulds in its own mould shop and in the production of prototypes in all common rapid prototyping methods.
The Specialists for Fine Tubes
Novoplast Schlauchtechnik in Halberstadt specialises in the extrusion of tubes and profiles in the diameter range 0.5 to 50 mm for industrial and medical applications. Some of these products are also processed further, for example by thermofixing or other special assembly and forming processes. Tube and profile extrusion is carried out on state-of-the-art equipment. Clean rooms of ISO classes 6, 7 and 8 have been set up for production in medical technology, which guarantees low-particle and low-germ production.
Due to similar customer requirements Novoplast Schlauchtechnik and Fleima-Plastic work closely together and also offer system solutions - consisting of tubing and medical components such as Luerlock connectors, drip chambers or roller clamps.