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Upon request, these services will be conducted under the direct supervision of a board certified veterinary pathologist. Full ophthalmologic evaluations are also available.

Species:  mice, rat, rabbit, dog, primate

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Available analytical techniques include scintillation counts of 14C and 3H labeled compounds, ELISA, LC/MS/MS, GC and HPLC.

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  7951	Rabbit Blood Sugar Method – Biopotency - USP
  7950	Rabbit Blood Sugar Method – Bioidentity - USP

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  7952	USP Glucagon

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• 3131	Purified Water Monograph – USP (conductivity and TOC)
  3980	Total Organic Carbon (TOC)
  3150	Particulate Matter (2 to 100 microns) – Light Obscuration Method
  6560	LAL – Bacterial Endotoxins Test – Kinetic Chromogenic or Turbidimetric

• 1334	Total Heterotrophic Count – Plate Count
  1335	Total Heterotrophic Count – Membrane Filtration
  	(For potential CFU > 1000, subsequent filtrations are $20.00 each.)
  1337	Total Coliform – Membrane Filtration
  	(There will be an additional charge of $40.00 if suspect growth occurs.)
  1344	Total Coliform – MPN
  	(There will be an additional charge of $40.00 if suspect growth occurs.)
  1339	Fecal Coliform – MPN (includes total coliform)
  1342	Pseudomonas aeruginosa – Membrane Filtration

  Other procedures from Standard Methods for the Examination of Water and Wastewater are available upon request.

• 1379	Polycarbonate Bottle, 1 Liter (For each purified water monograph, fill one bottle to capacity.)
  1380	Glass Bottle with Teflon Lined Cap, 1 Liter (reusable) (For each purified water monograph, fill one bottle to capacity.)
  1368	Specimen Cups, Sterile, 120 mL (For each microbiological analysis, fill one cup to capacity.)
  1383	TOC Sample Vials, 40 mL (For each TOC test, fill 2 vials to capacity.)
  1384	Test Tubes, Sterile, Non-pyrogenic, 15 mL (For each LAL test, fill one tube to capacity.)

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• 1410	USP (duplicate plating)
  	– category 1 products
  	– category 2,3,4 products
  1416	EP/BP (duplicate plating)
  	– parenteral, ophthalmic
  	– topical, oral
  1417	USP/BP/EP (duplicate plating)
  	– parenteral, ophthalmic
  	– topical, oral
  1411	CTFA (6 organisms)
  1412	CTFA (14 day re–challenge)
  1422	Japanese Pharmacopeia
  1413	Additional organism
  1415	Triplicate plating (per organism)
  1420	A.P.E Plate Counts by Filtration (per organism, per time point)
  1424	Validation of Plate Count Method used for AE Testing*

  
  * Additional fees may be incurred if the initial test parameters are not successful and retesting is required.

• 1329	Preparatory Tests (test method validation – see note below)*
  	Full Preparatory Testing Components:
  	– Aerobic bacteria plate count validation
  	– Yeast and Mold plate count validation
  	– E. coli screen validation
  	– Salmonella screen validation
  	– S. aureus screen validation
  	– P. aeruginosa screen validation
  1333	Screening Tests**
  	(Aerobic Plate Count, Yeast and Mold, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella and E. coli)
  Diagnostic Work on Suspect Organisms (fees are per isolate)
  1332	– Gram Stain
  1319	– Salmonella suspects – TSI biochemical test
  1320	– E. coli suspects – EMB agar morphology
  1321	– P. aeruginosa/E. coli/Salmonella suspects – oxidase test
  1322	– S. aureus suspects – coagulase test

  
  *USP requires preparatory testing to validate the specific test method that will be used in routine microbial limits testing of the product. By means of a challenge of 6 representative microorganisms, preparatory testing demonstrates the ability of the test method to recover microorganisms that could be present on a product.
  This test is generally required only once per product until a change is made in the product formula or manufacturing process.  The test fee indicated is typical.  Additional test fees may be incurred if the initial test parameters are not successful and retesting is required.
  **This test fee is typical. The price may vary depending on the nature of the product and test method specifics.

• 1301	Aerobic (Standard) Plate Count
  1304	Aerobic Plate Count with Yeast and Mold
  1302	Anaerobic Plate Count
  1303	Yeast and Mold Count
  1305	Coliform (MPN)
  1306	Coliform (Plate Count)
  1307	E. coli Screen
  1340	E. coli Confirmation (API)
  1309	Pseudomonas aeruginosa Screen
  1310	Salmonella Screen
  1341	Salmonella Confirmation (API)
  1311	Staphylococcus aureus (presumptive)
  1312	Coagulase Positive Staphylococcus

  Product specific validation testing is recommended or required for all routine microbiological analyses. Please call for a quote for your validation requirements.

• For Rush requests, we can have results in 10 to 24 hours. Because of the faster results capability, results reproducibility and the genetic strain tracking feature, Pacific BioLabs recommends the RiboPrinter for bacterial identifications.  Discount pricing is available for high volume projects.

  Bacterial Identification – RiboPrinter Genetic Method
  1510	Same Day Turnaround Time**
  1511	– 1 Day**
  1513	– 3 Days
  1517	– 7 Days
  1520	– 14 Days
  * If > 8 isolates are submitted together, the fee is reduced to the next longer TAT amount. ** Pure fresh culture required for ≤ 1 day TAT.

  Bacterial Identification – Other Methods

  In addition to the genetic method, Pacific BioLabs offers alternate techniques for microbial identifications.  Following gram stain and morphology of unknown bacteria, an appropriate identification method is selected.  The bacteria can be identified by the MIDI method, which is based on a fatty acid profile of an extract of the bacteria, or the API biochemical method.

   

  Gram positive rods – MIDI	Gram negative rods, Enterobacteriaceae – API
  Gram positive cocci – AP	Gram negative rods, other bacteria – MIDI

   

  1370	Bacterial Identification (MIDI GC with gram stain, morphology, catalase and oxidase.)*
  	– 1 Organism
  	– 2 to 5 Organisms
  	– 6+ Organisms
  1371
  	– 1 Organism
  	– 2 to 5 Organisms
  	– 6+ Organisms

  
  * The initial results of some bacterial identification testing may indicate more than one organism as a possible identification.  We can report the results of the initial test or perform additional biochemical confirmation testing to distinguish the most probable organism identification.  When additional confirmation testing is required, there will be an additional fee.

  1323	Bacteria Characterization – Biochemical & Morphological
  1324	Yeast Identification
  1325	Mold Identification
  1332	Gram Stain
  1343	Gram Negative Bacteria
  1326	Microorganism Morphology

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  1354	Fallout Plate, 100 mm, Tryptic Soy Agar (TSA), pack of 10
  1355	Fallout Plate, 100 mm, Sabouraud Dextrose Agar (SDA), pack of 10
  1350	Contact Plate, DE Neutralizing Agar, pack of 10
  1356	Contact Plate, Tryptic Soy Agar, pack of 10
  1357	Contact Plate, Sabouraud Dextrose Agar, pack of 10
  1358	Biotest Air Sampler Strip, TSA
  1366	Biotest Air Sampler Strip, SDA or Rose Bengal Agar
  1365	Biotest Centrifugal Air Sampler – Daily Rental
  1359	Sterile Buffer Solution w/Dacron Swab
  1368	Sterile Specimen Cups, Screw Cap, 120 mL
  1386	Surgeon’s Gloves, Latex, Sterile (available in sizes 6 to 8 ½)
  1387	Antiseptic Gel Hand Rinse, 4 oz. bottle

  Microbial monitoring supplies are usually shipped in coolers. There is a $12.00 packaging charge per supply order. Shipping charges are billed at cost. It is advisable to order supplies 7 – 10 days prior to the scheduled sampling date.

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  1360	Fallout Plate Count
  1361	Contact Plate Count
  1362	Biotest Air Sampler Strip Count
  1363	Buffer Solution – Aerobic Count (Membrane Filtration)
  Anaerobic counts available upon request.

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  6101	Direct Transfer – Immersion
  6103	Membrane Filtration by Vacuum Method
  6104	Membrane Filtration by Millipore Steritest™ Method

  
  For Bacteriostasis/Fungistasis tests by membrane filtration, 60 product samples are normally required.  This test includes performing three filtration sterility tests of 20 samples each.  For each simulated sterility test, one test organism is inoculated into the final 100 mL rinse of the membrane filter. The USP/EP combination test requires 8 organisms.

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  6219	Liquids (per organism, in triplicate: 3 organisms recommended)
  6221	Powders (per organism, in triplicate: 3 organisms recommended)

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  6201	Bioburden – Containers, Closures, Packaging  Materials
  Total Aerobic Bacteria and Fungi by Membrane Filtration Method
  6210	Bioburden – Process Fluids
  Total Aerobic Bacteria and Fungi by Membrane Filtration Method
  6222	Bioburden – Powders (Total Aerobic Bacteria and Fungi)
  6207	Bioburden – Total Anaerobic (with Total Aerobic Bacteria and Fungi)
  6209	Bioburden – Total Aerobic Spores (with Total Aerobic Bacteria and Fungi)
  6401	Biological Indicator Population Verification (3 spore strips)

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• Sterility Testing of Biological Indicators
  6806	10 Spore Strips and 1 or 2 positive controls – 15 mL SCDM
  6820	Each additional spore strip – 15 mL SCDM
  Product Only – Direct Transfer (Immersion) (20 products in SCDM, 20 products in FTM)
  6812	≤ 120 mL media
  6817	500 mL media
  6818	1000 mL media
  6825	2000 mL media

• 6807	Vacuum Filtration (Liquid)
  6808	Vacuum Filtration (Powder)
  6814	Millipore Steritest Filtration (Liquid)
  6813	Millipore Sterisolutest Filtration (Powder)
  6819	Extra Samples for Filtration Test (per sample)
  6834	Extra 100 mL Filter Rinses (per rinse beyond 3)
  6830	Steritest Filtration – Subsequent Subtest*
  6832	Vacuum Filtration – Subsequent Subtest*
  6829	Filtration Test – Exact Reconstitution (per sample)
  6831	Filtration Test – Exact Pooling – Dilution (per sample)

  
  All standard fees for sterility tests by membrane filtration are based on testing 20 samples, using one vacuum or Millipore filter unit, three 100 mL filter rinses, and culturing of the filter in FTM and SCDM.  Samples which require extraordinary preparation or filtration time will incur a surcharge.
  *For some products, it may not be possible (or desirable due to bacteriostasis or fungistasis properties) to run 20 samples through one filter unit.  A subtest consists of  using an additional vacuum or Millipore filter unit for a portion of the samples, three 100 mL filter rinses,  and culturing of the filter in FTM and SCDM.  For tests requiring subtests, one standard test fee will be billed, plus one subtest fee for each subsequent subtest that is required.

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• Gel Clot Method
  6499	Water
  6500	Liquids
  6509	Concurrent Assay of Sample Dilution
  6508	Non-concurrent Assay of Sample Dilution

  The gel clot method is semi-quantitative. For liquid samples with an EU level below test system sensitivity limits, the results will be reported as "less than (the test system limit)", e.g. 0.125 EU/mL for high purity water.  If an exact EU result is required, a kinetic method must be used.

  Kinetic Turbidimetric or Chromogenic Methods
  6560	Water
  6561	Liquids
  6562	Powders
  6567	Concurrent Assay of Sample Dilution
  6568	Non-concurrent Assay of Sample Dilution

• 
  

  This testing is performed on products and materials for which a specific kinetic LAL test method has not yet been established.  It generally involves testing additional dilutions of the product to address any inhibition or enhancement issues.  The validation testing also serves as product release testing for the lot(s) tested.  For some products, additional method development may be required and additional fees would apply.

  Kinetic Turbidimetric or Chromogenic Methods
  6552	– LAL Validation (one lot)
  6554	– LAL Validation (three lots, concurrently tested)

• United States Pharmacopeia (USP)
  7201	– 3 Rabbit Test (non-pyrogenic)
  7202	– Retest 5 Rabbits
  7236	– Sham Test (per rabbit)
  European Pharmacopeia (EP)
  7203	– 3 Rabbit Test (non-pyrogenic)
  7237	– Sham Test (per rabbit)
  Japanese Pharmacopeia (JP)
  7218	– 3 Rabbit Test (non-pyrogenic)
  7239	– Sham Test (per rabbit)

  For substances determined to be pyrogenic, there will be an additional charge per rabbit

• USP Safety Test
  7204	USP Safety Test (mice)
  EP Safety Test
  7219	EP Abnormal Toxicity – general (mice)
  7228	EP Abnormal Toxicity – immunosera/vaccines (5 mice, 2 guinea pigs)
  CFR Safety Test for Biological Products
  7207	– 2 guinea pigs, 2 mice
  7205	– retest (2 mice)
  7206	– retest (2 guinea pigs)