A.Laboratory Tests • Medical Device Safety Evaluation      ISO 10993 Biocompatibility Studies       Indentify the presence of potentially harmful effects of the  products       • Routine QC and Lot Release Testing      Bioburden Test     Measures the population of viable microorganisms on a product   or preparation.              Sterility Test       Provides assurance that your product is free from viable   microorganisms                Bacteriostasis / Fungistasis       Establishes the absence of interfering substances in the sterility   test.                Bacterial Endotoxin Test (LAL)      Quantitative evaluation of medical devices, drugs and water for   endotoxins              • Microbial Identification      Gram Stain and Morphological Identification     Culture isolation and Gram identification of bacteria.                    • Microbiological Analysis      Total Aerobic Plate Count       Total aerobic plate counts may be performed in compliance to   USP test requirements.                Total Coliform Count      Coliform counts for E. Coli, fecal coliforms and other coliform   counts are determined as an indication                USP Microbial Limits Test       USP microbial enumeration of non-sterile products and   identification of specified / objectional microorganisms                Growth Promotion Test       The Growth Promotion Test is performed on microbiological   culture media to assess the ability of the media to sustain   growth            • Disinfectant Validation Studies      Disinfectant Studies for Manufacturing Facilities     Under current Good Manufacturing Practice guidelines,   manufacturers must validate disinfectant regimens.              • Packaging and Barrier Tests      Accelerated Aging and Real-Time Aging Studies       EIG provides accelerated and real-time aging studies for medical devices and packaging materials         Seal Integrity Tests       Ensures integrity of porous packaging seals to maintain sterility contained therein.          Container and Closure System Integrity Testing     Physical and microbial challenge test to demonstrate the   integrity of a container / closure system.            • Environmental and Water Monitoring      Environmental monitoring     Routine microbiological surveillance helps maintain contamination   control in the aseptic manufacturing environment              Pharmaceutical and process water testing      Control and monitoring of the microbiological quality of water for   its intended use.            • Ethylene Oxide Sterilization Validation      Ethylene Oxide Residuals     EO, ECH and EG residual testing of the ethylene oxide sterilized   medical devices              Ethylene Oxide Dissipation Curve    A full dissipation profile for the sterilized article can be   determined to for validation of aeration times            • Plastics Test      USP Class I – VI Plastics Tests     USP In Vivo Biological Reactivity Tests (Class I-VI Plastics Tests).                    USP Containers – Plastics Test       Performance testing and chemical analyses of plastic containers.              DEHP Quantification and Screening       Phthalate screening of PVC medical devices including blood bags   and tubings.            • Biopharmaceutical Services       Biopharmaceutical Services    Specialized services to ensure potency, purity and effectiveness   of biologics.              • Proficiency Test Services      Proficiency Test Services    Proficiency Test Services are statistical quality assurance   programs that enable laboratories to assess their performance in   conducting        B.Validation and Calibration   Validation &Qualification      EIG has extensive experience with the Qualification of all types of Facilities, Utilities and various   Equipment types. We have successfully executed several projects, which incorporates information   obtained from the vendors as well as the commissioning effort. We can help you identify the best   approach to implementation given your current culture.    • Facilities and Utilities Qualification for CGMP systems   (Cleanroom [HVAC] Validation, Ethylene Oxide Sterilization   validation,Autoclave Validation, Depyrogenation validation,   Lypholization "Freeze-Drying" Validation…). • Equipment Commissioning for Pharmaceutical, Biotechnology   and Medical device equipment   • Laboratory Equipment Qualification.        EIG personnel have extensive experience with Process Validation and are at the forefront in   implementation of the new guidance for Process Validation. Our approach consists of the following    • Stage 1 - Process Design – Develop understanding of   process by obtaining information on process capability,   variability, and control from process development efforts   and prior knowledge. • Stage 2 - Process Qualification - Using Stage 1 process   understanding to gain enough confidence in process to   commercially distribute product  • Stage 3 - Continued Process Verification - Using information   obtained about the process during and from commercial   manufacturing/distribution to confirm that process is and   remains under control        • Calibration & Certification      Our measurement sciences customers in the biotechnology,   pharmaceutical, and medical device industries establish the most demanding standards for device calibration– EIG's expertise and use of top quality calibration standards enable us to meet those needs. EIG provides calibration and metrology services using extremely accurate secondary standards and standard reference materials that are traceable to NIST          Calibration Services:      • Analytical Balances and Scales • Temperature, Humidity, and Pressure Monitoring Chart   Recorders   • Storage Tanks, Freezers, and Refrigerators  • Temperature and Humidity Controlled Environmental   Chambers  • Digital Temperature, Humidity, and Pressure Controllers   • Central Monitoring Systems   • Analog Pressure, Magnehelic, and Vacuum Gauges   • Digital Multi-meters   • pH Meters   • Power Supplies   • RTD Simulation and Measurement   • Thermocouple Simulation and Measurement   • Glass and Digital Thermometers  • Timer Calibration             C.Engineering Services 1- Main Services    a) Design & Implement Main Electrical Panels    • Main & Sub Power Panels:-Construction , Modification or   Development  • Power Factor Correction Panels:- to saving the power  • "ATS" Panels & "UPS" Panels     (ATS: - Automatic Transfer Switch)   (UPS: - Uninterruptable Power Supply)  b) General Lighting          2- Complementary Services    a) Networking Systems      • Design & Implement Complete Network System in Plants   or Companies   b) Design & Implement any Type of Fire Alarm System    • Design is According to "International CSAA ®" Standards   (Conventional, Analog Addressable or Intelligent   Addressable Systems Types) • Safe the area with earlier Alarm   • For Production area, Chemicals lab,…..etc c) Design & Implement Internal Sound System      • For General Decisions • For Emergency Conditions as a warning   d) Design & Implement Interlock Systems      • For Restricted or Clean areas • For Restricted Labs:- Chemicals, Microbiology Labs,……etc   e) Design & Implement Access Login-Logout Systems      • To prevent any unauthorized persons to login some areas • To achieve the security for required areas   f) Design & Implement the Safety Systems against theft" Under Complementary Services         3- Production Lines Services      • Design & Implement any Control Panels for Production   Lines • Modify the Machines or Production Lines according to   requirements   Develop the Conventional Production lines to Modern   Production Lines (with PLC Systems)   Saving the Running & Maintenance time & Cost       4- Heating Ventilation Air Condition (HVAC) Services      • Design & Install for Heating Ventilation Air Condition and Follow up Insulation and Testing for   all HVAC Work. • Design & Install for Freezing & Cooling Station and Cooling Tower Station.