Process Validation & Equipment Qualification Services
In today’s biopharmaceutical industry, managing drug manufacturing process risks through appropriate process validation and equipment qualification is key to ensuring patient safety and speed to market.
Areas at risk in your process:
- Extractables and Leachables
- Sterilization
- Cleaning
- Storage
- Transportation
- Handling
- Process Design
- Process Performance
- Extreme Operating Parameters
Because our products are key components within your production process, their performance under your specific conditions should be demonstrated.
Critical equipment to be considered:
- Sterilizing-grade Filters
- Integrity Testing Equipment
- Single-use Components or Assemblies
- Sampling Devices
- Virus Removal Products
- Tangential Flow Filtration (TFF) Devices
- Chromatography and Tangential Flow Filtration (TFF) and Normal Flow Filtration (NFF) Equipments
Production process challenges are evolving along the drug development process. Our services are configured to adapt to your specific needs every step of the way.
Drug development steps:
The goal of our Provantage® services is to demonstrate that our products, when used with your drug product within specific process conditions, are reliable, robust, efficient, and provide the highest level of performance. Achieving this objective is a joint effort; we work hand-in-hand with you to exchange information and define the most efficient validation strategy.
Our Approach
Given that we are also a Biomanufacturing Producer, we understand your constraints. We are providing you with a combination of technical expertise, regulatory knowledge, rigor in our quality systems and personalized attention that only a global leader in life sciences technologies can offer.
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