Process Validation
A contingency plan, to reduce the risk of plant downtime
- Each of our suppliers and subcontractors is handpicked,
- All of our plants benefit from a fleet of modern equipment at the cutting edge of technology,
- Our manufacturing processes are subject to ISO 9001,
- Our workforce is versatile, but also continuously trained and sensitized to the demands of our customers.
Whether you are in the medical sector or whether your product must be manufactured with a delicate or unverifiable process, Plastitel provides process validation solutions. Validation is done according to FDA guidelines.
Validation must comply with three major areas:
- Design
- Qualification
- Continuous auditing
Process qualification is done in three steps
Plastitel has provided a multitude of process validations in a variety of sectors.
In order to ensure perfect validation, all information relating to the design and possible uses of the part must be clearly defined. Good communication between Plastitel and the customer must be maintained throughout this validation process.
1
Installation and qualification (IQ) in which equipment is defined and calibrated. It is imperative that the critical functions of equipment are understood and measurable in order to ensure that any changes (pressure loss, incorrect temperature) is quickly identified and corrected.
2
The second step is operation qualification (OQ). This phase is based on the product and equipment. It is at this stage that the limits of the parameters that determine the processes are ensured.
3
Process qualification (PQ) measures the manufactured product taking into account process variability. Once the third stage is completed, we are able to know if the process as it was designed allows for scaling up production while still meeting specifications.
