2018 North America Lab Services Fee Schedule

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1 Product Bioburden - ISO Bioburden sample pooling, sample item portion (SIP) and additional material fees may apply as required by the sample type. BIO110 Bioburden: Aerobic bacteria only per unit $99.00 BIO120 Bioburden: Anaerobic bacteria only per unit $99.00 BIO130 Bioburden: Fungi only per unit $99.00 BIO140 Bioburden: Spores only per unit $99.00 BIO210 Bioburden: Aerobic and anaerobic bacteria per unit $ BIO220 Bioburden: Aerobic bacteria and fungi per unit $ BIO230 Bioburden: Aerobic bacteria and spores per unit $ BIO310 Bioburden: Aerobic, anaerobic bacteria and fungi per unit $ BIO320 Bioburden: Aerobic bacteria, spores and fungi per unit $ BIO410 Bioburden: Aerobic, anaerobic bacteria, spores and fungi per unit $ BIO710 Bioburden: Pooling Fee, per pooled unit (plus cost of test) per unit $31.20 BIO715 Bioburden: Packaging Pooling Fee, per set w/ concurrent test (one result) per set $36.40 BIO720 Bioburden: Sample Item Portion (SIP) Preparation Fee, per set per set $ BIO730 Bioburden: Additional materials or manipulation per unit BIO735 Bioburden: Additional spore tubes, per tube per unit $21.80 BIO740 Bioburden: Additional dilutions, per dilution/org. type/sample qty per unit $36.40 BIO815 Bioburden: Standard MPN method per unit $94.00 BIO910 Bioburden: Recovery efficiency, repetitive recovery method, per unit per unit $ BIO920 Bioburden: Recovery efficiency, inoculated product method, per unit per unit $ BIO930 Bioburden: Recovery qualification using multiple organisms per unit BIO950 Bioburden: Protocol or Report fee Standard Plate Counts for Pharmaceuticals (non-sterile) - USP/EP Generally performed on liquids and powders for microbial enumeration tests (no product manipulation). Standard plate counts or total plate counts however do not provide differentiation of organism titers in a specific product. SPC110 Standard Plate Count: Aerobic bacteria per unit $57.00 SPC120 Standard Plate Count: Aerobic bacteria and fungi (fungal sel. plates) per unit $88.00 SPC130 Standard Plate Count: Molds and yeast per unit $57.00 SPC140 Standard Plate Count: Anaerobic bacteria per unit $88.00 SPC701 Standard Plate Count: Additional plated dilutions (plate counts) per unit $36.40 Sterility Method Suitability (B/F) and Product Sterility - USP/EP and ISO/AAMI Product Sterility tests include both a Cleanroom Fee plus Cost per Unit Fee; Suitability (B/F) recommended prior to Sterility Test. For routine product sterility tests two reads are performed as per USP/EP for interim and final; typically day 7 and day 14. BFS110 Sterility Method Suitability (B/F): USP/EP method w/ filtration - 6 org., 2 media per device $ BFS120 Sterility Method Suitability (B/F): USP/EP method w/ immersion - 6 org., 2 media per device $ BFS140 Sterility Method Suitability (B/F): ISO/AAMI method w/ immersion- 3 org., 1 medium per device $ BFS150 Sterility Method Suitability (B/F): Non-standard organism culture and maintenance per unit $1, BFS160 Sterility Method Suitability (B/F): Re-challenge test, per organism per unit $ PSC108 Product Sterility: Direct immersion (Cleanroom), <200 ml, EP/USP per unit $12.50 PSC109 Product Sterility: Direct immersion (Cleanroom), ml EP/USP per unit $16.50 PSC110 Product Sterility: Direct immersion (Cleanroom), ml EP/USP per unit $19.20 PSC111 Product Sterility: Direct immersion (Cleanroom), ml EP/USP per unit $19.20 AUX Nelson Laboratories, LLC All Rights Reserved Page 1

2 PSC112 Product Sterility: Direct immersion (Cleanroom), ml EP/USP per unit $25.00 PSC113 Product Sterility: Direct immersion (Cleanroom), > 3000 ml EP/USP per unit $35.00 PSC115 Product Sterility: Direct immersion (Cleanroom), <1L volume, ISO/AAMI per unit $19.20 PSC125 Product Sterility: Direct immersion (Cleanroom), >1L volume, ISO/AAMI per unit $42.50 PSC150 Product Sterility: Open membrane filtration (Cleanroom), EP/USP per unit $44.20 PSC155 Product Sterility: Closed membrane filtration (Cleanrooom), EP/USP per unit $46.80 PSC156 Product Sterility: Closed membrane filtration (Cleanroom) - Canister Fee, EP/USP per unit $68.00 PSC220 Product Sterility: Membrane filtration, sterile pathway (Cleanroom), EP/USP per unit $57.00 PSC710 Product Sterility: Cleanroom session fee per set $ PSC715 Product Sterility: Media transfer fee per unit $20.00 PSC720 Product Sterility: Daily reads for sterility test, per day per set $35.00 PSC730 Product Sterility: Additional time or materials fees (Cleanroom) per unit PSC901 Product Sterility: Special protocol or project (Cleanroom) per set PSC905 Product Sterility: Complex kit or device (Cleanroom) - extended TAT per unit PSC950 Product Sterility: Protocol or Report fee Additional time, manipulation and material fees are charged on an hourly rate or based on cost of materials. Biological Indicators and Sterilant Residuals Minimum fees apply for BI sterility tests and BI supply orders. BI population verification for total viable spore count. Biological indicator purchase, place and pull, and post-processing sterility culture test are now billed separately although bundled services are available. BPV110 BI Population Verification (USP), pooled results, 4 BIs per set $ BPV120 BI Population Verification (USP), individual results, 4 BIs per set $ BPV125 BI Population Verification (ISO), pooled results, 4 BIs per set $ BPV130 BI Population Verification (ISO), individual results, 4 BIs per set $ BPV150 BI Population Verification, custom protocol BIT210 BI Sterility: Immersion, Spore strips & discs (7 day), each per unit $8.30 BIT230 BI Sterility: Self-contained biological indicators, each per unit $4.10 BIT250 BI Sterility: Releasat method, per load (up to 20, plus positive) per set $ BIT255 BI Sterility: Releasat method, per additional BI per unit $8.30 BIT260 BI Sterility: BI Hospital test pack testing per BI $52.00 BIT610 BI Sterility: Processing placement & pull (by processing facility) - dependent on chamber size BIT620 BI Sterility: Parametric release only fee (by processing facility) Consult sales for a quote on test packs and bundled service discounts (BI, place/pull, BI sterility) BIT710 BI Sterility: Standard BI minimum test fee per set $ BIT715 BI Sterility: Self-contained BI minimum test fee per set $ BIT950 BI Sterility: Protocol or Report fee Biological indicator supplies and product inoculation fees BIT802 Sterilization Supplies (000654PQT): STERIS BIs, single species per BI $3.10 BIT805 Sterilization Supplies (000661PQT/STN062): CrossTex BI mini strips per BI $2.30 BIT806 Sterilization Supplies (007620): MESA BI Bacillus Atrophaeus 10^6, glassine envelopes per BI $2.30 BIT807 Sterilization Supplies: Self-contained BI BIT808 Sterilization Supplies: BIs, other or custom BIT815 Sterilization Supplies: Testpack (EPCD) purchase $11.75 AUX Nelson Laboratories, LLC All Rights Reserved Page 2

3 PCD100 Sterilization process challenge device (PCD) For process challenge devices and test packs, please consult the lab SPI110 Sterilization Product Inoculation: B. atrophaeus per unit $13.00 SPI120 Sterilization Product Inoculation: G. stearothermophilus per unit $18.20 SPI130 Sterilization Product Inoculation: C. sporogenes per unit $18.20 SPI140 Sterilization Product Inoculation: Wires per unit $18.20 SPI150 Sterilization Product Inoculation: Other organism or method SPI510 Sterilization Product Inoculation: Inoculation, EO exposure and sterility testing Ethylene oxide sterilant residual study fees EOR110 EO Residuals: EO & ECH (water ext.), one extraction - limited per device $ EOR111 EO Residuals: EO & ECH (water ext.), one extraction - limited, with aeration per device $ EOR120 EO Residuals: EO, ECH, & EG (water ext.), one extraction - limited per device $ EOR121 EO Residuals: EO, ECH, & EG (water ext.), one extraction - limited, with aeration per device $ EOR130 EO Residuals: EO, ECH and EG for liquid samples (no extraction) per device $ EOR310 EO Residuals: EO & ECH, ISO (water ext.), exhaustive, 1st extract -Prolonged or permanent per device $ EOR315 EO Residuals: EO & ECH, ISO (water ext.), exhaustive, additional extracts per device $ EOR410 EO Residuals: EO, ECH & EG (water ext.), exhaustive, 1st extract - Prolonged or permanent per device $ EOR415 EO Residuals: EO, ECH & EG (water ext.), exhaustive, additional extracts per device $ EOR500 EO Residuals: EO Headspace analysis (water ext.), one extraction - limited per device $ EOR510 EO Residuals: EO Headspace analysis (water ext.), exhaustive, 1st extraction per device $ EOR515 EO Residuals: EO Headspace analysis (water ext.), exhaustive, additional extracts per device $ EOR600 EO Residuals: EO only, per extraction per device $ EOR610 EO Residuals: ECH only, per extraction per device $ EOR615 EO Residuals: EG only, per extraction per device $ EOR620 EO Residuals: Exothermic test per device $ EOR622 EO Residuals: Methanol test for EO per device $ EOR950 EO Residuals: Protocol or Report fee For EO residual studies the Blank sample is charged as an additional extract. Bacterial Endotoxin Test (Pyrogen) Bacterial endotoxin test (BET) sample pooling and additional material fees may apply as required by the sample type. LAL110 Bacterial Endotoxin Test: Kinetic turbidimetric method per result $ LAL140 Bacterial Endotoxin Test: Kinetic turbidimetric method, water per result $ LAL150 Bacterial Endotoxin Test: Kinetic chromogenic method per result $ LAL151 Bacterial Endotoxin Test: Kinetic chromogenic method, water per result $ LAL155 Bacterial Endotoxin Test: Kinetic chromogenic method, suitability assay (sample prep, 5 dilutions) per result $ LAL156 Bacterial Endotoxin Test: Kinetic chromogenic method, unvalidated (1:1 dilution) per result $ LAL210 Bacterial Endotoxin Test: Gel clot method per result $ LAL610 Bacterial Endotoxin Test: Kinetic method - expedited, same day results per result $ LAL710 Bacterial Endotoxin Test: Kinetic method - concurrent dilution fee per result $ LAL711 Bacterial Endotoxin Test: Pooling fee, per pooled result per set $30.00 LAL730 Bacterial Endotoxin Test: Large device/kit or manipulation fee LAL740 Bacterial Endotoxin Test: Endotoxin-specific buffer test per result $ LAL750 Bacterial Endotoxin Test: Retest fee per result $ LAL901 Bacterial Endotoxin Test: Custom protocol LAL902 Bacterial Endotoxin Test: Validation - USP/EP per device $1, LAL950 Bacterial Endotoxin Test: Protocol or Report fee AUX Nelson Laboratories, LLC All Rights Reserved Page 3

4 Environmental Analysis Service and Supplies Environmental analysis tests include both an Environmental Report Fee plus Cost per Unit Test Fee, per order. As outlined in guidance standards environmental monitoring total plate counts (TPC) are incubated at high (aerobic) or low (fungal, yeast, mold) conditions. Water samples should be labled with time/date/location and shipped to the lab in cool pack containers (but not frozen) to minimize microbial change in transit. ENV110 Environmental Analysis: TPC single plate, high temp. incubation w/ extended low temp. per unit $17.20 ENV115 Environmental Analysis: TPC single plate, high temp. incubation only per unit $17.20 ENV120 Environmental Analysis: Swab samples, TPC high temp. incubation only per unit $41.60 ENV125 Environmental Analysis: Swab samples, TPC low temp. incubation only (fungal sel. plating) per unit $41.60 ENV130 Environmental Analysis: Swab samples, TPC high and low temp. incubation (fungal sel. plating) per unit $78.00 ENV135 Environmental Analysis: Swab samples, TPC high temp. incubation w/ extended low temp. per unit $78.00 ENV210 Water Tests (Microbial): Membrane filtration, aerobic bacteria per unit $46.80 ENV230 Water Tests (Microbial): Membrane filtration, fungi (fungal sel. plates) per unit $46.80 ENV240 Water Tests (Microbial): Membrane filtration, aerobic bacteria and fungi (fungal sel. plates) per unit $78.00 ENV250 Water Tests (Microbial): Membrane filtration, total coliforms w/ 2 replicates per unit $90.00 ENV700 Environmental Test: Report fee (routine) per report $ ENV710 Environmental Test: Trending and analysis per report $ ENV800 Environmental Supplies (Equipment): Daily location site monitoring and equipment shipping ENV830 Environmental Supplies (007276): Fallout agar plates, TSA ICR, pack 10 per pack $52.00 ENV840 Environmental Supplies (002094): Surface monitor, TSA contact plate, pack 10 per pack $52.00 ENV850 Environmental Supplies (N00041): Surface monitor, calcium alginate swab, pack 10 per pack $26.00 ENV860 Environmental Supplies (003183): Bottles for TOC sampling, pack of 10 per pack $68.00 ENV870 Environmental Supplies (000149): Bottles for conductivity sampling, pack of 10 per pack $68.00 ENV880 Environmental Supplies (001294): Polystyrene bottles for BET sampling, pack 25 per pack $36.40 ENV890 Environmental Supplies (001347): Bottle with thiosulfate pill (chlorinated water), pack of 10 per pack $52.00 ENV895 Environmental Supplies (001348): Bottle w/o thiosulfate pill (non-chlorinated water), pack of 10 per pack $52.00 ENV950 Environmental Test: Protocol or Report fee ENV955 Environmental Test: Site visit Ancillary Service Fees Organism identification standard 5 day service. For expedited service select 1 day or 3 day. IDG105 Organism ID - Genotypic identification, MicroSeq w/ Gram stain per isolate $ IDG200 Organism ID - 1 day: Genotypic, MicroSeq w/ Gram stain (pure culture) per isolate $ IDG205 Organism ID - 3 day: Genotypic, MicroSeq w/ Gram stain (pure culture) per isolate $ IDS200 Organism ID: A.P.I identification (manual, kit dependent) per isolate IDS210 Organism ID: Classic morphological to genus (manual) per isolate $ IDS510 Organism ID: Gram Stain only per isolate $38.20 IDS710 Organism ID: Subculture fee per isolate $33.30 CHM115 ph reported with other tests per test $33.30 PKG621 Packaging Validation: Strength & integrity tests PKG622 Packaging Validation: Microbial barrier performance PKG623 Packaging Validation: Aging studies SVR701 Radiation Sterilization: Dose mapping of verification dose SVR702 Radiation Sterilization: Dosimeters (8 Alanine) SVR710 Radiation Sterilization: Gamma dosing charges - Sterigenics (std) SVR711 Radiation Sterilization: E-Beam dosing charges - Sterigenics (std) AUX Nelson Laboratories, LLC All Rights Reserved Page 4

5 SVR712 Radiation Sterilization: Non-standard dosing charges (min. fee applies) SVR713 Radiation Sterilization: Gamma dosing charges - 3rd party SVR714 Radiation Sterilization: E-Beam dosing charges - 3rd party XDF100 Sample destruction and waste fee per unit $5.00 XMD100 Lab: Test method development or consult, per hour per hour $ XSP100 Lab: Shipping fee STAT Fees - Generally 100% for standard STAT and 200% for same day; consult lab for availability For general terms and conditions related to test serivces please visit: AUX Nelson Laboratories, LLC All Rights Reserved Page 5

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