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Medical Device Services

It is imperative to engage a testing company with expertise in regulatory compliance and contamination control. ALG’s reusable medical device testing facilities are U.S. FDA-regulated to meet all GLP standards (21 CFR Part 58). Our single-use medical device testing facilities comply with cGMP standards.

All test labs GLP/GMP compliant

Reusable Medical Device Tests (GLP Compliant)

Reusable Medical Device Validation

Reusable Medical Devices need to be reprocessed before reuse to ensure that the risk of contamination is minimized. The reprocessing must include cleaning (the physical removal of soil/contaminants) and either sterilization or disinfection (the deactivation of microorganisms). Before the device can be brought to market the process for each of these actions must be validated to prove that it is effective. At Analytical Lab Group we possess the knowledge, experience and infrastructure to perform these validations:

  • 510(k) Support
  • Sterilization (Steam)
  • Dry Time
  • Disinfection (Low Level, Intermediate Level, High Level)
  • Manual and Automated Cleaning (With Quantitative Endpoints – Protein, Hemoglobin, Carbohydrate)

Whether validating the Instructions for Use (IFU) already developed or helping to create one with our guidance, Analytical Lab Group will develop a separate testing protocol for each processing category that is agreed upon by both parties.
If the reprocessing parameters are not ready for validation our experience and knowledge give us the ability to help test parameters in a non-regulatory, R&D setting. Using a variety of detergents, disinfectants and processing parameters ALG can assist in finalizing a set of reprocessing instructions that can then go to the validation phase.

USP <1072> Disinfectant Qualification

A controlled medical device manufacturing cleanroom environment requires a sound disinfectant qualification program. Disinfectants utilized within these environments must be validated to confirm their effectiveness for use. Proper rotation of the disinfectants can be determined based on the data collected in this study.

  • Tube Dilution Method
  • Coupon Testing Using Immersion Recovery Method
  • Environmental Isolates and Viruses

High Level Disinfectant

  • Simulated use testing on flexible endoscopes
  • Bench testing, simulated use and in-use

Blood Glucose Meter/Point of Use Devices

Cytotoxicity Testing/Rinsing Studies

Single-use Medical Device Tests (GLP/GMP Compliant)

USP <61><62> Suitability Tests

  • USP <61> <62> Suitability Tests (Methods Validation) Price Includes Complete Suitability Test including Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) and 4 Pathogens
  • Validation of the test method per product for USP <61> <62> includes growth promoted media for bacteria, yeast and mold, calibrated pipettes and balances and ATCC cultures. Each dilution is considered a sample. Products tested with and without neutralizers are considered separate samples.

USP <61><62> Product Testing

  • USP <61> <62> Product Testing (TAMC, TYMC Specified Microorganisms for 4 pathogens)
  • Test to determine total number of bacteria, yeast and mold in product including low limit detection of objectionable organisms.

Growth Promotion Testing of Plates USP <61<62>

  • Growth promotion of testing of media in accordance with USP <61> <62>.

Microbial Identifications

  • I.D. of Microorganisms to Genus and Species
  • Genus ID
  • Gram Stain
  • Coagulase
  • Colony Morphology
  • DNA
  • Identification of microorganisms. Includes microscopy, staining, morphology, biochemical tests, metabolic profiles to determine microbial ID for bacteria, yeast and mold. Utilizes validated Vitek 2 automated ID system.

Bacterial Water Analysis

  • Bacterial Water Analysis (Total Bacterial Count, Total Gram Negative Count, Presence of Coliforms)
  • Includes heterotrophic plate count, total gram negative count, presence of coliforms. Samples tested at multiple volumes (1ml, 10ml, 100ml) are considered separate samples.

Bacterial Endotoxin Test for Water Samples USP <85>

  • Bacterial Endotoxin Test for Water Samples USP <85> Gel Clot Method
  • Detects and quantifies endotoxins in water samples from RODI/WFI systems.

USP <161> Bacterial Endotoxin and Pyrogen Tests for Medical Devices

  • Utilizing Gel-Clot Technique
    • Confirmation of labeled lysate sensitivity
    • Non-inhibitory concentration determination (limit test)
    • Test for interfering factors (inhibition/enhancement test)
    • Quantitative product testing
  • Utilizing Turbidimetric/Chromogenic Techniques (Photometric Techniques)
    • Assurance of criteria for the standard curve
    • Test for interfering factors (inhibition/enhancement test)
    • Quantitative product testing

ANSI/AAMI/ISO 11137 Bioburden for Medical Devices

  • Bioburden validation to determine recovery factor for medical device compliance to sterilization validation.
    • Bioburden recovery factor for medical devices (method validation)
    • Bioburden testing 
    • ANSI/AAMI/ISO 11137 sterility tests
    • VD max dose verification sterility
    • Method 1 dose verification study
    • Membrane filtration test for sterility
    • Direct transfer test for sterility
    • Media growth promotion testing
    • Method Suitability (bacteriostasis and fungistasis testing)

Bioburden Studies (AAMI and USP)

  • Test to determine total number of bacteria, yeast and mold in product.

Gamma and E-Beam Irradiation Validation (AAMI)

  • Bioburden method development
  • Bioburden recovery studies
  • Bioburden studies for dose setting

AAMI Sterility Suitability

  • Validation of the test method

AAMI Sterility

  • Test for sterility of the sample, includes growth promoted media and validated equipment.

Environmental Monitoring

  • Determines cleanliness of manufacturing areas, production rooms and cleanrooms. Includes growth promoted media for bacteria, yeast and mold. Includes validated incubation, laboratory analysis, colony counts, genus id and final reports.
  • Includes cleanroom sampling and validation

Current USP <71> Growth Promotion Test

  • Growth promotion testing of broths.

Current USP <71> Sterility Suitability Test

  • Current USP <71> Sterility Suitability Test (Required to be Performed One Time on Each Formulation) (B+F Test)
  • Validation of the test method per product for USP <71> sterility testing.

Current USP <71> Membrane Filtration Sterility

  • Current USP <71> Membrane Filtration Sterility – Aqueous Solutions
  • For large volume parenteral solutions (LVP), call for quote
  • Test for sterility of the sample, includes growth promoted media, validated equipment and both negative and positive controls.
  • Sample volume and sample quantity are per USP <71> Table 2 and Table 3.

Current USP <71> Direct Transfer Sterility Test

  • For large devices – call for quote
  • Test for sterility of the sample, includes growth promoted media, validated equipment. Sample volume and sample quantity
  • are per USP <71> Table 2 and Table 3.

USP <85> Bacterial Endotoxin Validation Test

  • USP <85> Bacterial Endotoxin Test Validation Gel Clot Method
    • Validation of the test method per product for USP <85> endotoxin testing using gel clot method. Determines which dilution of product to carry out USP <85> inhibition/enhancement test.

USP <85> Bacterial Endotoxin Test of Product

  • Detects and quantifies endotoxins from gram negative bacteria in product.
  • Note: required endotoxin limit to be provided by client, and NIC to be performed

USP <85> Endotoxin Challenge Vials (ECV)

  • ECVs are used to determine endotoxin control in depyrogenation validation studies.

Sterility Testing of Biological Indicators

  • Verifies microbial lethality of sterilization methods
    • Steam
    • Radiation
    • Dry heat
    • ETO

USP <55> Biological Indicators - Resistance Performance Tests

  • Total Viable Spore Count (Population Verification)
  • Biological Indicator (BI) Population Verification (3 BIs Required)
  • Purity Testing
  • Verifies accuracy and purity of manufacturer’s label claim for spore populations
  • Identification

Package Integrity Testing

  • Microbial immersion test
  • Dye leak test

Water Chemical Testing

  • TOC
  • Conductivity
  • Nitrates

Bacterial Water Analysis

Microbial Identification

Compressed Air/Gas Testing

ALG Compliance Tests

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