Facility Validation
We can help design your entire facility’s validation. Our key regulatory competencies cover the entire pharmaceutical, biotechnology and medical devices spectrum for regulated facilities worldwide. Our breadth of experience covers laboratory/clinical trial facilities, manufacturing facilities and other business areas.
Some examples of the type of facilities that Invensys Validation Technologies has experience with includes:
- Liquid and semi-solid dosage forms
- Medical device facilities (21 CFR Part 820)
- Blood facilities (21 CFR Part 606)
- Biologicals (21 CFR Parts 600, 601, 610)
- Animal health facilities
- Clean rooms
- Sterile environments
- Active pharmaceutical ingredients (API)
- Manufacturing
- Research and development
- New and renovated facilities
- Parenterals and sterile facilities
- Liquid and semi-solid dosage facilities
Invensys Validation Technologies experience with facilities, data management system, clinical trials, and documentation systems are listed below:
- Facility / environment monitoring systems
- Building management systems (BMS)
- Document management systems (DMS)
- Warehouse management systems (WMS)
- Computer integrated manufacturing systems (CIM)
- Maintenance Systems
- Electronic data management systems (EDMS)
- Databases, spreadsheets and statistical software and systems
- Training database and management systems
- Clinical data systems
Equipment Validation
Equipment validation has become a focus in most pharmaceutical operations. Invensys Validation Technologies provides the following equipment validation services:
- Auditing of equipment files and validation documentation against current good manufacturing practices (cGMP) requirements
- Equipment qualification:
—Installation qualification (IQ) to ensure appropriate installation, specifications description, capabilities, and standard operating procedure (SOP) requirements
—Operational qualification (OQ) to ensure predictable operation within expected ranges, tolerances, and specifications
—Performance qualification (PQ) to ensure reproducible operation throughout expected ranges and limits over time - Detailed chamber temperature and/or humidity mapping of controlled temperature equipment
- Customized SOP development for calibration, maintenance, operation, and monitoring activities
Invensys has equipment validation (qualification) expertise with many different types of process equipment including:
- Dispensing, blending, milling, dry/wet granulation, compaction
- Fluid bed dryers and tray dryers
- Pelletization
- Tablet compression presses and tablet coating pans: manually operated to fully instrumented
- High-speed piston fill and rotary encapsulators
- Topicals processing equipment: jacketed vessels, reactors mixers, homogenizers, and pumps
- Sterile powder filling/lyophilization
- Parenteral, ophthalmic, and sterile solution process trains
- Packaging equipment, and fully integrated lines for tablets, liquids, and semi-solids
- Labeling systems using vision technology
- Stability chambers (ICH stability standards), laboratory incubators
- Tableting
- Robotics
- Sterilizers
- Vision
Laboratory Systems and equipment validation experience includes:
- Laboratory information management systems (LIMS)
- Laboratory data acquisition systems (LDAS)
- Chromatography
- Analytical / QC Laboratory instruments (HPLC, GC, mass spectrometers, particle size counting)
