Castle Validation Services

Castle Validation Services, Inc., offers years of expertise on a wide-range of equipment qualification; in addition to qualification services, we offer Factory Acceptance Testing (FATs), Site Acceptance Testing (SATs) and commissioning services.  This equipment includes but is not limited to:

• Utilities: Purified Water, Water for Injection (WFI), Clean and Pure Steam, HVAC, Chilled Glycol, Process Air, Oxygen, Nitrogen, and Carbon Dioxide Systems.
• Support Systems: Steam Sterilizers, Depyrogenation Ovens, Glasswashers, Clean-In-Place Systems, Lyophilizers, Isolators, Filter Integrity Testers, Process Piping, Bio-Safety Cabinets, Incubators, Freezers, Refrigerators, Stability and LN2 Chambers.
• Bio-Process Systems: 100 to 15,000 L Bioreactors, Fermentation Systems, Continuous Centrifuges, Roller Bottle Robots, Homogenizers, Filter Trains, Ultrafiltration Systems, Various Prep and Hold Tanks, Chromatography Skids and Columns.
• Pharma-Process Systems: Blow-Fill-Seal Machines, Blenders, Granulators, Milling Systems, Tablet Presses, Coaters, Fluid Bed Dryers, Filling and Capping Process Lines, Bar Code Readers, Vision Systems, Labeling and Packaging Equipment.
• Computer Control Systems: Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Supervisory Control and Data Acquisition Systems (SCADA), Digital Automation Systems and Building Management Systems (BMS).
• QC Laboratory Systems: LIMS, HPLC, Cedex Viability and Cell Density Analyzers, Spectrophotometers, GC, UV-VIS, TOC Analyzers, Titrators, Densitometers, Calorimeters, Microbial Identification Units and Plate Readers.

Castle Validation Services, Inc., has developed various types of Validation Master Plans (VMPs) and programs for single and multi-product facilities as a clear path to compliance.  Not only do we prepare these master plans and programs, but we provide full implementation, coordination and management of these plans from protocol preparation to execution to final summary report generation.  These plans include:

• Cleaning VMPs
• Process VMPs
• Equipment VMPs
• Analytical Methods VMPs
• Re-Validation Programs
• Equipment Change Control Programs

We will work closely with your Validation, Quality Assurance, Quality Control, Manufacturing and Process Development departments to develop thorough compliant plans and programs that are achievable within your time-lines, budget and needs.  We will support development of recovery studies and sampling training programs.  In addition, you gain a flexible, controlled plan or program that you continue to use and develop as your company expands or regulations change.

In addition to the above validation and qualification services, we provide a full range of compliance and regulatory services.  Our personnel have diversified backgrounds encompassing validation, quality assurance, quality control, regulatory affairs and manufacturing related experience to fit all of your needs, such as:

• Internal Compliance Audits
• Vendor Audits
• Training Services
• 483 Observation Resolution
• Gap Analysis
• SOP Preparation
• Batch Record Review