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ASTM D6978 Test Method for Resistance of Medical Gloves to Permeation by Chemotherapeutic Agents
Category:
Protective Gloves
ASTM D6978 Standard Description
ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drug
ASTM D6978 Standard Introduction
ASTM D6978 is a standardized method specifically designed to evaluate the resistance of medical glove materials to permeation by chemotherapy drugs. It is used to assess the protective performance of glove materials when exposed to such drugs.ASTM D6978 provides a comprehensive evaluation method for determining the resistance of medical gloves to chemotherapy drug permeation, thereby ensuring their protective performance in clinical environments.
ASTM D6978 Scope of Application
ASTM D6978 is applicable to medical gloves.
ASTM D6978 Sample extraction medium
In ASTM D6978, the extraction medium refers to the medium used during testing to simulate actual working conditions and evaluate the permeation behavior of chemotherapy drugs through glove materials.According to this standard, two main media are used:
(1) Chemotherapy Drug Solution
Chemotherapy drug solutions are used as the outer extraction medium, representing the drug solution in contact with the external surface of the glove.
The selected chemotherapy agents exhibit high permeability and toxicity, representing typical chemotherapy drugs encountered in clinical applications. The specific agents include:
◎ Cyclophosphamide: An anticancer chemotherapy drug with high water solubility and the ability to readily permeate glove materials.
◎ Doxorubicin: A highly effective anticancer drug with strong permeation capability, presenting significant challenges to glove materials.
◎ 5-Fluorouracil: Commonly used for the treatment of various cancers and characterized by strong tissue penetration.
◎ Cisplatin: A platinum-based anticancer drug containing heavy metal elements, requiring high chemical resistance from glove materials.
◎ Vincristine and Etoposide: Cytotoxic drugs that may react with chemical components of glove materials and are used to evaluate material chemical stability.
◎ Irinotecan: A drug with relatively small molecules that can easily pass through molecular gaps within glove materials.
(2) Simulated Human Sweat
Simulated human sweat is used as the inner extraction medium and placed on the inner surface of the glove to simulate conditions caused by hand perspiration.The composition of simulated human sweat typically includes deionized water or artificial sweat to reproduce the humidity conditions inside gloves. In some tests, additional sodium chloride (NaCl) solution may be added to better simulate the ionic environment.
ASTM D6978 Testing Instruments
To ensure test accuracy, reproducibility, and sensitivity, ASTM D6978 specifies the following key testing equipment:
(1) HPLC (High-Performance Liquid Chromatograph)
◎ Function: Used to measure the concentration of chemotherapy drugs collected from the inner extraction medium and evaluate drug permeation rates.
◎ Detection sensitivity: Capable of detecting permeation rates as low as 0.01 µg/cm²/min.
◎ Detection wavelength: Each chemotherapy drug exhibits a specific absorption wavelength during HPLC analysis, generally within the range of 200 nm to 400 nm.
◎ Mobile phase: Acetonitrile-water or methanol-water systems are commonly used as mobile phases.
(2) Permeation Testing Device
◎ Function: Used to secure and separate the inner and outer sides of the glove specimen, preventing contamination of the inner testing medium by chemotherapy drugs.
◎ Structure:
Upper layer: Chamber containing chemotherapy drug solution (outer medium).
Middle layer: Glove material acting as the permeation barrier.
Lower layer: Chamber containing deionized water or simulated sweat (inner medium).
(3) Temperature Control System (Constant Temperature Equipment)
◎ Function: Maintains a constant temperature of 35°C to simulate actual glove usage conditions.
◎ Principle: The temperature of the test chamber is controlled through a heating system to ensure consistency throughout the test environment.
ASTM D6978 Test Method
◎ Sample Preparation: A complete glove specimen is cut, ensuring that the specimen is flat and free from cracks or defects. The specimen is secured in the test fixture, and the inner and outer surfaces are properly sealed.
◎ Drug Contact: A specified volume of chemotherapy drug solution is added to the outer surface of the specimen. Continuous contact between the chemotherapy drug and glove material is maintained to allow interaction between the drug and the glove surface.
◎ Process Monitoring: The exposure time is typically 240 minutes, with the temperature maintained at 35°C to simulate hand temperature conditions.
◎ Permeation Monitoring: Samples are collected from the inner surface of the glove at 30-minute intervals. The collected solutions are analyzed using HPLC, and the permeation rate is calculated to evaluate the glove material’s resistance to chemotherapy drug permeation.
ASTM D6978 Relevant Drugs Introduction
|
Drug Name |
Category |
Function |
Test Challenge |
|
Cyclophosphamide |
Alkylating agent |
A commonly used chemotherapy drug with high water solubility. |
Highly permeable and easily passes through glove materials. |
|
Doxorubicin |
Antibiotic |
A highly effective anticancer drug with high cytotoxicity. |
Strong penetration ability and high sensitivity to material properties. |
|
5-Fluorouracil |
Pyrimidine-based anticancer drug |
Used for the treatment of various types of cancer. |
Small molecules that easily diffuse and permeate. |
|
Cisplatin |
Platinum-based anticancer drug |
A highly effective chemotherapy drug containing heavy metal ions. |
Requires high chemical resistance of glove materials. |
|
Vincristine |
Antimicrotubule drug |
Mainly used for the treatment of hematological malignancies. |
May chemically react with glove materials. |
|
Etoposide |
Antitumor drug |
Inhibits cell division. |
Highly toxic with strong penetration capability. |
|
Irinotecan |
Topoisomerase inhibitor |
Cytotoxic drug used for various cancer treatments. |
High molecular weight and easily adsorbed. |
ASTM D6978 Basis for Determination
Nonconforming:If the glove is exposed to chemotherapy drugs for 240 minutes and the permeation rate exceeds 0.01 µg/cm²/min at any measured time point, the glove shall be considered nonconforming.
Qualified:If the permeation rate remains below 0.01 µg/cm²/min at all measured time points during the specified test period, the glove is considered qualified.
Note:
Permeation rate: If the permeation rate of the chemotherapy drug is below 0.01 µg/cm²/min, the glove material is considered to provide qualified protection against chemotherapy agents.
Time requirement: The test commonly monitors permeation performance for 240 minutes to ensure that gloves maintain their barrier properties during prolonged exposure.
SATISFY offers testing services for personal protective equipment and medical supplies, including protective clothing, gloves, and masks. We provide expert interpretation, data analysis, and improvement recommendations to support protective products entering global markets. Please contact SATISFY customer service for more information.
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