MEDICAL DEVICE SERVICES: Service List/Test Codes

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• Biocompatibility Testing

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    All samples submitted for biocompatibility testing should be sterilized under the same conditions that will be used for the final product. Extracts and extraction conditions must be specified when samples are submitted for testing. If you cannot submit sterile samples, please select the appropriate sterilization process.

  • Sterilization Processes for Biocompatibility Test Samples

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      5994	Ethylene Oxide (100% ETO – 12 hour cycle)
      6001	E-beam or Gamma Sterilization (~ 25 kGy)
      6000	Steam Sterilization (121°C for 15 to 30 minutes)
      5990	Chemical Sterilization

  • Biocompatibility Testing – In Vitro Procedures
    
    
    • Cytotoxicity (Tissue Culture)

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        6521	Elution Test – ISO - L929 Cells (triplicate plates)
        6522	Agar Diffusion – ISO - L929 Cells (triplicate plates)
        6523	Direct Contact – ISO - L929 Cells (triplicate plates)
        6540	Elution Test – USP - L929 Cells (duplicate plates)
        6541	Agar Diffusion – USP - L929 Cells (duplicate plates)
        6542	Direct Contact – USP - L929 Cells (duplicate plates)
        6537	Cell Viability Quantification and % Reactivity
        6538	Surface Area Calculation and Sample Preparation – This may be required for elution testing of complex devices.

    • Inhibition of Cell Growth

      • 6525	1 Dose Level (L929 Cells)
        6526	ICH - additional dose

    • Hemocompatibility Testing

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        Hematology – In Vitro
        6512	Hemolysis – Direct Contact, Rabbit Blood (duplicate tubes)
        6550	Hemolysis – Direct Contact, Rabbit Blood (triplicate tubes)
        6513	Hemolysis – Sample Extract, Rabbit Blood (duplicate tubes)
        6551	Hemolysis – Sample Extract, Rabbit Blood (triplicate tubes)
        6575	JP Hemolysis Test
        6548	Hemolysis – ASTM Direct Contact
        6549	Hemolysis – ASTM Elution
        Coagulation – In Vitro
        6536	Prothrombin Time Test (PT)
        6537	Partial Thromboplastin Time Test (PTT)
        Complement System
        6511	Complement Activation Assay
        Platelets
        6539	Platelet Aggregation

    • Genotoxicity Testing

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        6530	Ames Mutagenicity Test – Five strains, saline or DMSO Extracts
        6517	Mouse Lymphoma
        6518	Chromosomal Aberration
        6519	Mouse Micronucleus Assay
        Other genotoxicity tests are available – please inquire.

    
    
  • Biocompatibility Testing – In Vivo Procedures
    
    
    • Systemic Toxicity – Acute

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        7209	Systemic Injection Test – USP – plastics or elastomeric closures, per extract
        7263	Systemic Injection Test – JP – plastics or elastomeric closures, per extract
        7198	Material Mediated Pyrogen – Sham Test (per rabbit)

    • Intracutaneous and Irritation Tests

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        7210	Intracutaneous Tests – USP (2 rabbits) – plastics or elastomeric closures, per extract
        7925	Intracutaneous Test – ISO (3 rabbits)
        7282	Primary Eye Irritation (FHSA guidelines) – 6 rabbits, 24, 48, and 72 hour observations
        7284	Primary Skin Irritation (FHSA guidelines) – 6 rabbits, 24 and 72 hour observations
        7920	Intraocular Irritation
        7232	Oral Mucosa Irritation Test (includes histology)
        7235	Vaginal Irritation Test – ISO (6 rabbits, includes histology)
        7285	Ocular Irritation Test – ISO – 3 rabbits, 1, 24, 48, and 72 hour observations
        7286	Skin Irritation Test – ISO – 3 rabbits, 1, 24, 48, and 72 hour observations
        	Other Mucosal Irritation Studies

    • Skin Sensitization Studies

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        7501	Closed Patch Test (ISO)
        7502	Buehler Method (EPA)
        7507	Dose Level Determination
        7503	Maximization Test – Magnusson Kligman Method (12 test guinea pigs)**
        7505	Maximization Test – Magnusson Kligman Method (11 test guinea pigs)** – Each additional guinea pig
        7510	Re-challenge (including 5 naive controls)
        7508	Positive Controls (historical validation)
        7509	Positive Controls (concurrent)
        7512	Murine Local Lymph Node Assay (LLNA) (includes positive control)

        * These tests include historical positive controls. A positive control group is a group treated with a known sensitizing agent. A positive control group must be included with a sensitization test to demonstrate that a sensitization response can be elicited under the conditions of the test. There are two types of positive controls. A concurrent positive control group is one conducted at the same time as a particular test. Alternatively, Pacific BioLabs runs a historical positive control group at least once a year. Any test performed during the year under the same conditions can be compared to this control. The historical control minimizes cost and the use of animals.
        ** The Maximization Test using 12 test animals is recommended for all critical sensitization determinations. The larger test group size allows for a more accurate assessment of sensitization potential and has a lower incidence of false positives.

    • Thrombosis – In Vivo

      • 6516	ISO Dog Thrombogenicity Testing

    • ISO Intramuscular Implant Test – 3 rabbits *

      • 7930	7 day observation period
        7931	14 day observation period
        7932	30 day observation period
        7933	60 day observation period
        7934	90 day observation period
        7935	180 day observation period
        7936	365 day observation period
        7230	Histopathology of Implant Sites (required)

    • Intramuscular Implant Test – 2 rabbits *

      • 7212	5 day observation period (USP)
        7213	7 day observation period (USP)
        7230	Histopathology of Implant Sites (per site)

        * Implantation of samples performed by percutaneous deposition. Surgical implants are available upon request.

    • Classification of Plastics Tests – USP (Class I to VI)

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        7220	Class I
        7221	Class II
        7222	Class III
        7223	Class IV (includes 7 day implant)
        7225	Class V
        7227	Class VI (includes 7 day implant)

    • Subacute/Subchronic Toxicity (OECD/ISO)

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        7233	IP Subacute Toxicity with Histopathology
        7234	IV Subacute Toxicity with Histopathology
        7258	IP Subchronic Toxicity with Histopathology
        7259	IV Subchronic Toxicity with Histopathology
        7299	Preclinical Device Evaluation – Surgical Procedures (surg_models.asp)

    • Contact Lens and Ophthalmic Product Studies

      • 7290	21 Day Ocular Irritation – includes corneal oxygen metabolism determination
        7291	Microbiological Validation of Lens Disinfection Regimen

  
  
• Pyrogen And Biological Safety Tests
  
  
  • Pyrogen Tests

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      United States Pharmacopeia (USP)
      7201	3 Rabbit Test (non-pyrogenic)
      7202	Retest 5 Rabbits
      7236	Sham Test (per rabbit)
      7198	Material Mediated Pyrogen
      For substances determined to be pyrogenic, there will be an additional charge of $45.00 per rabbit.

  • Safety Tests

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      7204	USP Safety Test (mice)
      7219	EP Safety Test (mice)

  
  
• Water Testing

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  • Chemical and Physical Tests

    • 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

  • Microbiological Analyses – Water

    • 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.

  • Water Sampling Supplies

    • 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.)

  
  
• Microbial Environmental Monitoring

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    6301	Environmental Survey – Microbiological (Performed by Pacific BioLabs Personnel)

  • Microbial Environmental Monitoring Supplies

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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.

  • Microbial Samples – Incubation, Enumeration and Report

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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.

  
  
• Microbial Identification

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    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.

    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.

  • 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

    • 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

  
  
• Device Cleaning And Disinfection

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    1. Cleaning, Disinfection and Sterilization Validation Protocols
    2. Cleaning Validation Studies
    3. Disinfection Validation Studies
    4. Sterilization Validation Studies
       1. Ethylene Oxide
       2. Steam Sterilization at 121°C to 132°C
       3. Flash, Gravity and High Vacuum Cycles
       4. Liquid Chemical Sterilization
       5. Dry Heat Sterilization and Depyrogenation
       6. VHP (Hydrogen Peroxide Gas)

    Please call about Sterrad hydrogen peroxide gas plasma sterilization or Steris System 1 Processor Sterilization.

• Biological Indicators

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  • Product Inoculation

    • 6702	B. subtilis (ethylene oxide), 103 to 108/sample
      6703	G. stearothermophilus (steam), 103 to 106/sample

  • Spore Strips

    • 6401	Spore Strip Population Verification – USP Method – 3 spore strips
      6404	Exposed Spore Strip Population (count unknown)
      	See "Sterility Assurance Tests" for Sterility testing of exposed biological indicators

  
  
• Sterility Assurance Tests

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  • Bacteriostasis/Fungistasis (Sterility test and dose audit method validation)

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      Immersion (Direct Transfer)
      6100	3 organisms – SCDM (Dose Audits)
      6101	6 organisms – 3 in FTM and 3 in SCDM (USP Sterility Tests)
      6103	Membrane Filtration by Vacuum Method
      6104	Membrane Filtration by Millipore Steritest™ Method
      6102	Growth Promotion of Media (per organism, in duplicate)

  • Bioburden Method Validation – Recovery Study

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      6220	Exhaustive Recovery (3 – 5 extractions per sample)
      6218	Simulated Recovery (spore inoculation, per sample)
      6230	Screening for the Release of Substances Adversely Affecting Bioburden Estimates (from AAMI/ISO 11737-1: 3 organisms, in triplicate)

  • Bioburden Analyses

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      Total Aerobic Bacteria and Fungi by Membrane Filtration Method
      6201	Small Devices
      6202	Medium Size Devices, Small Kits
      6203	Large Devices, Large Kits, Papers, Fabrics
      6206	Bioburden – Total Aerobic Bacteria by Plate Count Method
      Total Aerobic Bacteria Only by Membrane Filtration Method
      6240	Small Devices
      6241	Medium Size Devices, Small Kits
      6242	Large Devices, Large Kits, Papers, Fabrics
      6207	Bioburden – Total Anaerobic (with Total Aerobic Bacteria and Fungi)
      6209	Bioburden – Total Aerobic Spores (with Total Aerobic Bacteria and Fungi)
      Unless otherwise requested, the membrane filtration method will be used for all samples with filterable extracts.
      6204	Bioburden – Packaging (Contact Plate)
      6205	Bioburden – Packaging (Swab/Membrane Filtration)
      6210	Bioburden – Process Fluids (Membrane Filtration)
      1335	Bioburden – Water (Aerobic Bacteria by Membrane Filtration)

  
  
• Sterilization Validations

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    9756	Sterilization Process Validation Protocol Preparation

    For initial sterilization process validations, cGMP regulations require a written validation protocol. Pacific BioLabs will customize a sterilization validation protocol to meet individual client requirement. Once the initial validation is successfully completed, no additional validation protocols are normally required for subsequent revalidation (i.e. dose audits, EO cycle revalidation or subsequent single lot validation for the same product using the same method.)

  • Radiation Sterilization Validation - Microbiological

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      Initial Validations

      In an initial validation, a protocol, bioburden method validation and B/F test (dose audit method validation) are required. Additionally, each of the ANSI/AAMI/ISO methods also requires bioburden testing: 10 samples for single lot validations or 30 samples for frequently produced lots (10 samples from each of 3 lots). To complete the initial testing, each method requires either a dose audit of sublethally irradiated samples: 100 samples for Methods 11137-2 Method 1 and 15844 or 10 samples for VDmax. For large samples that do not fit into sterility test containers, SIP preparation is also required.

      Revalidation – Quarterly Dose Audits
      In quarterly dose audits, bioburden of 10 samples and a dose audit (AAMI/ISO Dose Audit) of sublethally irradiated samples are required. If SIP preparation (sterility_tests.asp#Sample Item Portion (SIP) Preparation) was required in the initial validation, it will be required for any revalidation.

    • Radiation Sterilization Validation – VDmax

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        9756	Validation Protocol
        9750	Sample Item Portion (SIP) Preparation (for large products) – single lot validation (39 samples) – complete 3 lot validation (59 samples)
        6201-6203	Bioburden - Total Aerobic Spores & Fungi – single lot validation (10 samples) – complete 3 lot validation (30 samples)
        6218, 6220	Bioburden Method Validation – Recovery Validation
        6230	Adverse Substance Screening
        6100	Bacteriostasis/Fungistasis (Dose Audit Method Validation)
        Dose Audit – 10 samples in SCDM
        6802	≤ 120 mL
        6803	500 mL
        6804	1000 mL
        6805	2000 mL
        6857	Verification Dose Calculation Report
        	Validation Summary Report (optional)

    • Radiation Sterilization Validation – AAMI/ISO 11137-2 Method 1 or AAMI Method 15844

      • more info >>

        9756	Validation Protocol
        9750	Sample Item Portion (SIP) Preparation (for large products) – 132 samples (AAMI 15844) – 152 samples (AAMI 11137)
        6201-6203	Bioburden - Total Aerobic Spores & Fungi – single lot validation (10 samples) – complete 3 lot validation (30 samples)
        6218, 6220	Bioburden Method Validation – Recovery Validation
        6230	Adverse Substance Screening
        6100	Bacteriostasis/Fungistasis (Dose Audit Method Validation)
        Dose Audit – 100 samples in SCDM
        6837	40 mL
        6838	120 mL
        6839	500 mL
        6840	1000 mL
        6841	2000 mL
        6857	Verification Dose Calculation Report
        	Validation Summary Report (optional)

    
    
  • Ethylene Oxide Cycle Validation – AAMI/ISO Methods

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      A typical EO cycle validation consists of exposure of product and B. subtilis biological indicators in fractional and half cycles, followed by sterility testing. The number of samples to be tested varies with the size of the EO sterilization chamber. Fees for sterility testing associated with customized ETO sterilization validation studies will be based on the number of spore strips and products tested, and the media volume required to test product samples. Additional testing normally performed as part of the validation is bioburden, bacteriostasis/fungistasis and ethylene oxide residuals.

  
  
• USP Sterility Tests

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  • 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

      Sterility testing of medical devices by fluid path available upon request.

  • 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
      6880	Self Contained Biological Indicators, 1 – 20
      6881	Each additional S.C.B.I.

  
  
• LAL Bacterial Endotoxins Tests – USP

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  • Gel Clot Method

    • 6499	Water
      6500	Liquids
      6502	Medical Devices (Immersion, < 1000 mL LAL negative water)
      6503	Medical Devices (Immersion, > 1000 mL LAL negative water)
      6504	Medical Devices (Fluid Path, < 1000 mL LAL negative water)
      6505	Medical Devices (Fluid Path, > 1000 mL LAL negative water)
      6509	Concurrent Assay of Sample Dilution
      6508	Non-concurrent Assay of Sample Dilution

      The gel clot method is semi-quantitative. For medical devices produced in lots of greater than 100 units, 10 samples are required. One test is performed on a composite of the 10 samples. Typically, the sample composite is tested at half of the client specified endotoxin limit. For cerebrospinal fluid contact, the average device limit in a 10 sample composite test is 2.15 endotoxin units (EU). For most other devices, the average limit in a 10 sample composite test is 20 EU per device. When successful, the interpretation for the test will be reported as follows: "These samples pass the test for bacterial endotoxins at 1/2 the endotoxin limit for medical devices." 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

    • 6563	Medical Devices (Immersion, < 1000 mL LAL negative water)
      6564	Medical Devices (Immersion, > 1000 mL LAL negative water)
      6565	Medical Devices (Fluid Path, < 1000 mL LAL negative water)
      6566	Medical Devices (Fluid Path, > 1000 mL LAL negative water)
      6567	Concurrent Assay of Sample Dilution
      6568	Non-concurrent Assay of Sample Dilution

      The kinetic test methods are quantitative. Generally, the resulting number of EU/mL determined in the test is reported. In some instances, a "less than detection limit quantity" may be reported.

  • LAL Validation – Inhibition and Enhancement

    • Gel Clot Method
      6506	LAL Validation (one lot)
      6514	LAL Validation (three lots, concurrently tested)
      Kinetic Turbidimetric or Chromogenic Methods
      6552	LAL Validation (one lot)
      6554	LAL Validation (three lots, concurrently tested)

  
  
• Physical Tests
  
  
  • Accelerated Aging of Medical Devices – 1 year

    • 6609	3 weeks at 55ºC w/ 75% R.H., 3 weeks at 55ºC w/ < 20% R.H.

      The above accelerated aging interval is based on guidance provided in ASTM 1980-99 Standard Guide for Accelerated Aging of Sterile Medical Device Packaging and ANSI/AAMI/ISO 11607-1997 Packaging for terminally sterilized medical devices.
      Alternate temperature and humidity conditions are also acceptable and available at Pacific BioLabs.

  • Packaging Tests

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      6630	Package Expiration Dating Validation Protocol

      A typical package expiration dating study includes accelerated aging of packaged products plus packaging tests after each of several aging periods (e.g. 1, 3 and 5 year equivalency). Also, aged products are usually returned to the client for physical evaluation and testing. A laboratory report specifying aging conditions, room temperature equivalency and sample storage dates is provided for each sample return date. We can follow your protocol or write a protocol to meet your specific requirements.

    • Environmental Stressing (optional) plus Package Integrity by Dye Penetration
      
      

      • 6602	Package Integrity by Dye Penetration
        	– 13 sample recommended (10 test samples and 3 positive control)

    • Environmental Stressing (optional) plus Package Integrity by Microbial Challenge
      • 
        

        6601	Package Integrity by Microbial Challenge - Small Device
        6606	Package Integrity by Microbial Challenge - Medium Device
        6607	Package Integrity by Microbial Challenge - Complex Device
        6608	Package Integrity by Microbial Challenge - Large Device
        	– B.I. Dust Method: 13 sample recommended (10 test samples and 3 positive control)
        6640	Package Burst Test
        6641	Package Creep Test
        6644	Package Distribution Simulation
        6646	Seal Peel Test

    
    
  • Particulate Matter

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      3152	Light Obscuration Method (2 to 100 microns) – 1 sample (small medical device) – 2+ samples (per sample)
      3154	Microscopic Method (>10 and >25 microns) – 1 sample (small medical device) – 2+ samples (per sample)

      The medical device is rinsed with filtered water (0.2 µm pore size). The particulate test is run on the rinse water. Usually, results are reported as particles per mL. There is an additional charge for the sample handling required for larger and/or more complex medical devices such as I.V. bags and tubing assemblies.