Our personnel’s expertise covers a broad range of validation, manufacturing and quality services from early process development stages to full scale operation and certification. The following table summarize our experience with twenty seven companies:
| Company | Type | Services Provided |
|---|---|---|
 Abbott Barceloneta, PR | Biotechnology – Parenterals | *Develop SOPs for Mixing Tanks, Containers, Freezers, Refrigerators, and Stir Plate *Develop Preventive Maintenance Procedures *Develop & Execute IQ /OQ for Mixing Tanks, Freezers, Refrigerators, Stir Plates *Manage of SOPs Control Number System *Manage of Calibration Process for New Equipment *Manage External Contractors and Service Suppliers Work Schedule |
 Allergan Hormigueros P.R. | Medical Devices - Sterile | *GMP Audit for General Calibration Program and Computer System Procedures *GMP Audit for Validation Documentation *SOPs Development |
 Amgen Juncos, P.R. | Biotechnology - Parenterals | *Qualification /Validation of: .Buffer Tanks, Mixing Tanks, Storage Tanks, Fillers (TL and Cozzoli), Stoppering Units, (SPU), West Capper, Tray Loaders. .CIP, Manual Cleaning Mixing Studies, Medial Fills, and Manufacturing Process (for syringe and vials products). .Steam sterilization of Manufacturing Tanks .TOC Recovery Studies. .New Product Stability Lots and Clinical Lots .Vials Manufacturing Process for NESP Product .Syringe Manufacturing Process for GCSF product .Steam in place (SIP) for mixing tanks and storage tanks. *Development o ICOS Sterilization Cycle *Computer Validation of: .TL Filler Computerized Control .West Capper Control System .Tray Loader Control System .Vials Washer Control System .Depyrogenation Tunnel Control System *GMP Audit of Qualification and Validation Documents of: .Process Validation .Cleaning Validation .CIP .Swab Recovery Study .Facilities and Utilities *Consulting Services for: .Smoke Profile Tests for Aseptic Manufacturing Area .Compressed Air Re-Qualification. *Preparation of Process Validation *Summary Reports for Steam Sterilization, Fermentation and Purification Processes. *Develop and Execute Capabilities Studies for the Product Mixing Process *Risk Analysis for Cleaning Validation Approach |
 Boehring Ingelheim Petersburg, VA | Bulk Chemical | *IQ/OQ Protocol Development for Stability Environmental Test Chambers, USP Purified Water System and HPLC Units *CAPA Management *GMP Audit of Cleaning Validation Protocols and Reports *Batch Record Development *Conduct Risk Analysis for Laboratory and Manufacturing Equipment and Processes |
 Boston Scientific (formerly Guidant) Dorado, P.R. | Medical Devices - Sterile | *IQ/OQ/PQ and Computer Validation (CSV) of: .FTIR .Differential Scanner Calorimeter (DSC) .UV- Vis Spectrophotometer *Conduct Risk Analysis for Qualification Approach base on Equipment Proposed Use *Develop and Conduct FAT & SAT for Laboratory Equipment |
 Cardinal Health Manufacturing B.V. Humacao, P.R. | Medical Services | *Develop and Execute Temperature Mapping Studies for Refrigerators, Freezers and Storage Rooms. *IQ/OQ/PQ for Aseptic Manufacturing Facility *IQ/OQ/PQ for Compressed Air System and Nitrogen Distribution System *Consulting Services for Analytical and Manufacturing Deviations and Investigations. |
 CB Fleet Laboratories, Inc. Lynchburg, VA U.S.A. | Personal Healthcare | *Working on process validation of laxative products solutions and hyperosmotic laxatives. *Provided support to the validation team, preparing and executing IOQ protocols and summary reports for manufacturing and packaging equipment. *Prepared and executed process validation protocols as well as summary reports for validation lots of different products. |
 CooperVision (formerly Ocular Sciences) Juana Diaz, P.R. | Medical Devices – Sterile Contact Lenses | *GMP Audit for Existing Qualification Documentation Packages for Analytical Laboratory and Warehouse. *Qualification of Analytical Laboratory Equipment: -UV-Vis Spectrophotometers with Computers Application -GC with Computers Application -HPLC with Computers Application -FTIR with Computers Application -Refrigerators -Incubators -PH Meters -Water Baths, -Viscometers -Karl Fisher -Colorimeters -Electronic Microscope with Computer Application for Visual Inspection -Zonometer (Visual Inspection of Surfaces Finish) *Method Optimization and Validation (Chemistry & Microbiological) *Audit of Bio burden System, CAPA and GLP *CAPA Management Consultant *Process Filtration Improvement and Validation *IQ/OQ/PQ HVACs with Computer Application *Temperature Mapping Study *Qualification of Facilities and Utilities *Process Validation *Product Transfer Support *SOPs Development *Conduct Statistical Evaluation of Process Performance *IQ/OQ/PQ for Manufacturing Equipment: -Mixing Tanks -Mixers with Computer Application *IQ/OQ/PQ Nitrogen Generation System *IQ/OQ/PQ for Packaging Line *IQ/OQ/PQ for Alcohol Storage Tanks and Distribution System |
| Electro Biology Guaynabo, P.R. | Medical Devices | *GMP Audit of Deionized Water System Qualification Packages |
 Glaxo Smith Kline Cidra, P. R. | Solid Dosage Manufacturer | *Provide Regulatory and Compliance Support as Part of the Remediation Plan due to Compliance Consent Decree signed with the FDA -SOPs Development -Document Translation -Conversion of Existing SOP Program to a Computerized System |
| Heyer-Schulte NeuroCare, Inc. (Currently Integra NeuroSciences) Añasco, P.R. | Medical Devices | *GMP Audit of: -Information System Operation and Documentation -Change Control Program -Labeling printing Devices and Control System -Stability Program -Regulatory Submission *IQ/OQ/PQ CSV of: -Data Matrix Labeling Printing System -Information System Including Purchasing & Receiving, Shop Data, Shop Floor and Inventory Control Modules |
 Jansen Products Gurabo, P.R. | Solid Dosage Manufacturer | *GMP Audit of: -SOPs Program -Utilities and Facilities Qualification Packages -Existing Facilities and Utilities Condition -Facility Drawing and Sampling Points Identification *Qualification of Analytical Equipment with Computers Application Software *Qualification of Manufacturing Equipment: Bin Blenders, Colletes Granulators, Mixers, Lifters and Bowl Hoisters. *Facilities and Utilities Qualification -Clean Steam Generation System -New Chilled Water System (3Chillers) and Controllers. -Compressed Air Systems. -Plant Steam. -Re-Heat Skids. -Electrical Power and Emergency Generator (1,500 KVA) -HVACs and Controllers *Develop and Provide Training on -Validation Principles -Part 11 |
 LifeScan, Inc. Cabo Rojo, P. R. | Medical Devices | *GMP Audit of: Test Procedures and Validation Packages for: -Burst Test Peel Strength -Helium Head Space -Helium Leak Rate *Quality System Audit for: -Product Stability Program -Change Control -Calibration -Validation Program and Documentation |
 Lilly del Caribe Carolina, P. R. | Biotechnology - Parenterals | *Qualification of: -Facilities and Processing Equipment -Utilities (Nitrogen, Helium, Argon, Compressed Air) -Fermentation and Purification Equipment -Collection and Dilution Tanks |
| Lilly del Caribe Mayaguez, P. R. | Bulk Chemical | *Qualification of: -Facilities for Microbiological and Chemical Laboratories -Utilities (HVAC, Power Generator, Vacuum, Compressed Gases) |
| Mentor del Caribe (currently Ciba Vision) Cidra, P.R. | Medical Devices – Intra Ocular Lenses | *Consulting Services for: -Analytical Laboratory Methodology and General Procedures Evaluation, Preparation and Training -GMP Audit of the Millennium Data Acquisition Qualification Document *Qualification /Validation of: -Data Acquisition Systems with HPLC, GC, UV-Vis and other Laboratory Equipment -Development and Assessment of General Laboratory Operational Procedures -Laminar Flow Hoods (Certification) -New and Modified Chemical Analytical Methods, Including: ->Solvent Analysis by GC ->GC Determination of Methyl Methacrylate Monomer in PMMA Lenses ->GC Determination of Methyl Methacrylate Monomer in Raw Materials and Distilled MMA ->Molecular Weight Determination of Clear UV IOLS and Compound. ->Determination of Refractive Index Procedure ->Determination of Light Transmission Using P-E Spectrophotometer ->Determination of Residual UV Absorber in Acrylic Lenses and Compound 400 by HPLC. ->Testing the Purity of 2-Hydroxyethyl Methacrylate Monomer by GC. ->Determination of Residual Extractable In memorylens by HPLC. ->Purified 4-Methacryloxy 2-Hydroxybezophenone Analysis ->Determination of the Stabilizer Hydroquinone Monomethyl Ether in Acrylic Esters. ->Determination of the acid Content in Acrylic Esters. ->Determination of Residual EGDMA and MMA Monomer Melting Point Measurement. ->Determination of Acetone in Memorylens Buttons Using GC. ->Procedure for AIBN Solubility in MMA. ->Water Content Determination of Memorylens Buttons ->Determination of Wet Refractive Index of Memorylens *Qualification (IQ/OQ/PQ) of ARS Sterilizer and its Controller *Product Transfer *IQ/OQ/PQ for HVAC Units *Validation of Formulation Processes |
 Pall Life Sciences Fajardo P. R. | Filter Manufacturer | *Perform Risk Analysis *IQ/OQ of Fusion Welders, Industrial Oven, and Walking Freezers |
| OMJ Pharmaceuticals San German, P. R. | Biotechnology - Parenterals | *Computer Validation for Millennium Data Acquisition Systems with Respective Ancillary Instrumentation. *Develop and Execute Manufacturing Mixing Studies to Support NDA Submission *Validation Manufacturing Processes -Filling Vials and Ampules -Mixing *Qualification of Control Systems for: -Finn-Agua I, II and III steam Sterilizer -Endotoxin Removal Macroscint Stoppers in Icos Machine. -Domino Printers with Applicable Software. -Labeling Inspection System at Packaging and Incoming -Depyrogenization Tunnel -Qualification/Validation of: ->Finn Aqua Steam Sterilization Process ->Steam Sterilization for Rectors Tanks, Trays, Vials, Glassware and Stoppers ->ETO Sterilizers *Microbial Challenge for Siliconized Stoppers *Qualification and Validation of: -Endotoxin Removal Macrosint Stoppers Machine -Filtration Process -Stoppering Process for Vials and Ampules *Execute Media Fills for Vials and Ampules *Develop and Execute Mixing Studies for process optimization *Develop SOPs for Equipment Operation and Control *GMP Audit of existing qualification/validation packages for several equipments *Conduct Statistical Evaluation of Process Performance *IQ/OQ/PQ HVACs, Potable Water System, UPS, Compressed Gases and Vacuum *Warehouse Mapping Studies *Develop and Execute Process Capability Studies *IQ/OQ/PQ Storage Freezers at extremely Low Temperatures |
| PACO Puerto Rico, Inc. Canovanas, P.R. | Packaging Services | *IQ/OQ/PQ of Compressed Air System |
 Pfizer Vega Baja, P. R. | Solid Dosage Manufacturer | *Conduct Statistical Evaluation of Process Performance *IQ/OQ/PQ Commissioning of: -Filter Integrity Tester with Computer Application -FTIR with Computer Application -UV-Vis Spectrophotometer with Computer Application -Hamo Parts Washer & Dryer with Computer Application -UPS -Water Chillers and Controllers -Laboratories Facilities -Laminar Flow Hoods -Compressed Gases (Nitrogen, Propane, Hydrogen, Argon, Acetylene, Nitrous Oxide, Helium and Air) -Potable Water System -HVAC Systems -Manufacturing Plant Environmental Re-qualification -Steam Generation and Distribution System -USP Purified Water System -Soft Water System (Cold & Hot) -Foil Printing Machine -Heat Exchangers -Dedusters *IQ/OQ/PQ Commissioning for Manufacturing Equipment: -Bin Blenders -Colletes Granulators -Fluid Bed Dryer -Flow Metering System -Metal Detectors -Fette Tablet Presser with Computer Application -Hata Tablet Presser with Computer Application -AZO Transfer System -Conveyors -Comil Mills -Coating Sprayer -Imatic 200 Encapsulator Machine with Computer Application -Precisa Checkweighers with Computer Application -PK Blenders -Manufacturing Tanks *Develop and Execute Protocols for: -Cleaning Validation for Manufacturing and Packaging Equipment -Product Reformulation -Optimization of Dry Products Through Statistical Evaluation -Product Manufacturing Trials *GMP Audit of: -Manufacturing Process and Documentation for Readiness for NDA Submission -USP Water System Validation Packages -Validation Documentation for Chilled Water, Plant Steam, Compressed Gases, And Vacuum System *Execute Product Transfer *Computer Validation for Poligram Macro-Pactor Control System *Develop and Conduct FAT & SAT for Manufacturing Equipment *IQ/OQ/PQ for Sampling Booth *IQ/OQ/PQ of Manufacturing Facilities (Compounding, Coating, Encapsulation, Printing, Packaging) *CSV for -Cartoner Machine -HVAC Control System -PK Blender Control System |
| Reedco & Dentco Humacao, P. R. | Consumer Products | *Qualification / Validation of: -Millennium Data Acquisition System Composed of Ten (10) HPLCs and Two (2) GCs *GMP Audit of: -Installation and Operational Qualification Documents for a Data Acquisition System |
 Roche Ponce, P. R. | Medical Devices | *Development of SOPs for IT Department *GMP Audit of existing IT practices and procedures |
| Sartorious Yauco, P. R. | Filters Manufacturing | *Computer Validation for a Getinge Sterilizer Control *Validation of Steam Sterilization Cycles |
| Sociedad de Microbiólogos de Puerto Rico | Professional Society | *Seminar on Equipment Qualification |
 Schering Plough Las Piedras, P.R. | Solid Dosage Manufacturer | *IQ/OQ/PQ/ for -HVACs -Compressed Air -USP Purified Water System -Deionized Water System |
 Tyco (USSC) Ponce P.R. | Medical Devices | *IQ/OQ/PQ for Laboratory Ovens and Water Baths |
 Warner Chilcott Fajardo P.R. | Solid Dosage Manufacturer | *IQ/OQ/PQ for: -HVAC Units -Compressed Gases (Air and Nitrogen) -Manufacturing Facilities |