Validation Services

FULL LIFE CYCLE

We offer validation services for all types of manufacturing and packaging equipment. Our main expertise is in pharmaceutical inspection systems for particle and cosmetic defects, such as: Eisai/Bosch, Wilco, Brevetti, Seidenader and Nikka Densok. With over 40 years of combined experience in the pharmaceutical industry, our technical knowledge and the commitment to our customers are the keys to the success of your validation projects.

We offer validation services as applicable to the following...

Equipment, systems, and processes including:
- Functional Requirements
- Systems Specifications
- Validation Master Plan
- Factory Acceptance Tests
- Commissioning, Traceability Matrix
- Site Acceptance Tests; Installation
- Operation, and Performance Qualification
Cleaning validation
Computer Systems validation
21 CFR Part 11
Knapp Statistical Study
Facilities design consulting

Other services offered:

Inspector training
Manual Inspection for determination of Rejection Probability using Knapp approach
Smoke Profile Testing (for clean rooms)
Particulate Monitoring for area classification

Product & Technology Transfer

Our staff has experience with FDA and other international regulatory agencies and can assist with the following:

In-house assessment
Preparation of Technology Transfer Documents (TTD)
Evaluation of manufacturing process for improvement and troubleshooting
Equipment selection and system design consulting
Quality investigations