MICROBIOLOGY          A. Bioburden Analysis          1. Total Count ? Aerobic (MBA)          2. Total Count ? Anaerobic (MBN)          3. Aerobic Membrane Filtration (MFA)          4. Exhaustive (MBE)          5. Aerobic ? Spore Count (MBS)          6. Most Probable Number (MPN)          7. Contact Lenses ? (Soft) (10 units) (MBA-C*)          8. Contact Lenses ? (Rigid Gas Permeable) (10 units) (MBA-C*)          9. Total Fungal Count (MBF)          * There will be an additional charge if contacts are in solution     B. Microbiological Identification (Program Accredited via (AIHA)          1. Spore Stain (MSS)          2. Gram Stain (MIG)          3. Mold / Culture (MIM)          4. Biological Indicator (MIB)          5. *Fatty Acid (MGC)          6. Biochemical (MBC)          7. PCR Analysis (PCR)          8. *API (API)          * To include initial set up cost     C. Growth Promotion Test          1. Aerobic (GPA)          2. Anaerobic (GPN)     D. Recovery Studies          1. Product (MRP)          2. Biological Indicator (E.O.) (MRB)          3. Biological Indicator (Steam) (MRS)     E. Susceptibility (Kirby Bauer)          1. Antimicrobial Screening (MSK)          2. Antimicrobial Screening (Weekend) (MSK-W)      ----------------------------------      WATER ANALYSIS     In accordance with current Standards, United States     Pharmacopeia Guidelines, and Standard Methods.          A. Total Coliform Test (W1)     B. Total Coliform Confirmation (WCX)     C. Total Count / W3 (if applicable) (W2)     D. Water Sampling ? Dilution (W3)     E. pH / Conductivity (W4)     F. Fecal Coliform (WFC)     G. Fecal Coliform Conformation (WFX)     H. USP XXXIV Purified Water (TOC) (UPW)     I. Total Dissolved Solids (TDS)     J. Nitrate / Nitrite (NIT)     K. Total Suspended Solids (TSS)     L. Total Count (Mold) (W2M)     M. Total Chlorine (PPM) (WCL)     N. Enterococci Analysis (WEC)     O. Enterococci Confirmation (WEX)     P. Total Organic Carbon (TOC) (TOC)     Q. Appearance (APW)     R. Calcium (WCA)     S. Sulfate (WSA)     T. Ammonia (WAM)     U. Heavy Metal (WH)      ----------------------------------      STERILIZATION SUPPORT SERVICES          A. *ANSI/AAMI/ISO 11137/TIR27 ? Radiation Qualification     (Protocol is required)          1. Master Specification (MS)          2. SIP Preparation (SIP-P)          3. SIP Qualification (SIP-Q)          4. Irradiation Dose Service (AUDT)          5. **VDmax Qualification (VDQ)          6. **VDmax Audit (VDA)          Final price may vary based on bioburden volume,          sample size and/or irradiation charges. See sterility          test section for additional services. Request Dynatec          Protocol for additional assistance. Ask Dynatec for          details of their ?TURNKEY? process. **Includes Bioburden          and Sterility Testing. Does not include dosing. Please          see ?Microbiology? Section for further requirements.     B. Dosing          1. Ethylene Oxide (DOSE-E)          2. Heat (DOSE-H)          3. Radiation (DOSE-R)          4. Ultra -Violet (DOSE-UV)     C. Ethylene Oxide ? Validation Studies (EVS)     D. Dry Heat or Steam ? Validation Studies (DSV)          Moist Heat (STL)     E. Irradiation ? Validation Studies (IVS)     F. Medical Device Disposal (MDD)     G. Reusable Medical Device ? Validation AAMI/TIR No. 12-1994      ----------------------------------      STERILITY SUPPORT     Ethylene Oxide Residual Analysis ? ISO 10993-7          A. E.O. Residual Analysis (EOA)     B. Additional Extractions (ECH/EG)     C. EO to EG Conversion (E2G)     D. Expedite/Weekend          1. EO Analysis (EOA-W)          2. Additional Extractions (ECH/EG-W)          3. EO to EG Conversion (E2G-W)     E. Biological Indicator ? Dvalue Studies (DV)          Dry Heat (DVH)          Ethylene Oxide (DVE)          Radiation (DVR)     F. Dissipation Curve (DC)      ----------------------------------      CHEMISTRY     Testing conducted in accordance to Standard Methods,     A.O.A.C or ISO Standards,protocol development is required.          A. Calorimetric Analysis (CA)     B. % Purity by Chromatography (PC)     C. Particulate Count (Microscopy) (PCM)     D. Spectroscopy (SPS)     E. Mass Spectroscopy (MSS)      ----------------------------------      LAL ANALYSIS     In accordance with FDA Guidelines and US     Pharmacopeia Guidelines          A. Standard (10 units) (LAL)     B. Standard Weekend (LAL-W)     C. 8-Hour Release (LAL-1)     D. Re-test (LAL-T)     E. Qualification (EIG)     F. Quantify Pyrogen Level (LQN)     G. Turbidimetric (TLAL)     H. Chromogenic (CLAL)      ----------------------------------      CONSULTING SERVICES          A. Consultation (CS-2)     B. GMP/GLP Audit (CS-3)     C. On-Site Sampling (El Paso) (OSS-E)     D. On-Site Sampling (Juarez) (OSS-M)      ----------------------------------      STERILITY TEST     Testing conducted in accordance to AAMI/ISO     Standards and or USP Guidelines.          A. Spore Strip Immersion in glassine (Media required ? 15 mL) (STS)          Spore Strip Immersion Weekend (Media required ? 15 mL) (STS-W)          Self Contained Biological Indicators (STI)          Self Contained Biological Indicators ? 4 hour release (SSS)          Cycle Validation (Media required ? 15 mL) (STS,SEQ)          *Price based on annual volume     B. Product Immersion (STP)          Product Immersion (Weekend) (STP-W)     C. Bacteriostasis / Fungistasis          1. Aerobic (Media Required ? 40 mL) (STBF-1)          2. Aerobic (Media Required ? 100-400 mL) (STBF-2)          3. Anaerobic (Media Required ? 40 mL) (STBF-3)          4. Anaerobic (Media Required ? 100-100 mL) (STBF-4)          The above listed services are conducted in accordance with U.S.P.          Guidelines utilizing A.T.C.C. acknowledged test microorganisms.     D. Product Inoculation, based on suspension of 106 (SPI-1)          Call for B. stearothermophilus pricing      ----------------------------------      ENVIRONMENTAL TESTING     The following fees reflect laboratory service only. Please consult     Dynatec personnel regarding pricing for on-site sampling at your facility          A. Surface Sampling (ESS)          Standard Plate Count     B. Air Sampling (ESA)          Strip Count     C. Anderson Air Sampling (six stage) (EAN)     D. Particulate Air Sampling (1 to 10 samples) (EAS-1)          Particulate Air Sampling (11 and up) (EAS-2)     E. Swab Method (EAW)     F. Compressed Air Analysis          1. Carbon Dioxide (ECD)          2. Moisture (EM)          3. Oil Content (EOC)          4. Dew Point (DP)     G. Tape Lift (TLA)     H. Air-O-Cell Assay Kit (AOC)      ----------------------------------      CLEANROOM ANALYSIS     The following laboratory services are conducted in accordance with     ISO/IEC/EN Standards, Classification of Air Cleanliness.          A. Differential Pressure (DPA)     B. HEPA Filter Efficacy (HFE)     C. Temperature Profile (TPE)     D. Method Development (CS-M)     E. Disinfectant Efficacy Assay (CS-D)     F. Air Flow Velocity (AFV)     G. Cleanroom Classification (CRC)     H. Hood (LAF) (CRH)      ----------------------------------      FOOD TESTING     Conducted in accordance with Official Methods of analysis of A.O.A.C.     International. Sample should be frozen and shipped in accordance with     Standard shipping conditions for perishables.          A. Salmonella, Biocontrol (FTS)     B. E. Coli, MPN (FTE)     C. Coliforms, MPN (FTC)     D. Staphylococci (coagulase positive) (FTST)     E. Aerobic Plate Count (FTPC)      ----------------------------------      E.P.A. STUDIES          A.O.A.C. Disinfectant Efficacy      ----------------------------------      PHYSICAL TESTING     ASTM. Protocol and Validation required.     *Conducted in accordance with TIR17.          A. Seal Strength (PTS)     B. Accelerated Aging Studies (AAS)     C. Peel Test (PT)     D. Presence of Blood (BLD)     E. Dye Penetration (DYE)      ----------------------------------      CYTOTOXICITY     Testing conducted in accordance with ISO and FDA biocompatibility     requirements. Requires Master Specification/Protocol. Testing     conducted in accordance with USP/ISO requirements.          A. Elution Test ? USP ? L929 Cells (CYT-E)     B. Agar Diffusion ? ISO ? L929 Cells (CYT-A)     C. Direct Contact ? USP ? L929 Cells (CYT-D)      ----------------------------------      REPORT FEES          A. One formal report is included per test request. (AR)          Additional reports are available.     B. Fax documents and E-mail are available as follows:          1-2 pages (FX-1)          3-4 pages (FX-2)          5 and up (FX-3)     C. Weekend fax (FXW)     D. Electronic Mail ? Administrative service charge (E-mail)      ----------------------------------      COURIER SERVICES          A. B.I. Pick-up/delivery (C-1)     B. Other (C-2)     C. Additional (weekend) (C-W)