ISO 10993 • E&L Qualified

Medical Devices & Primary Packaging

Ethylene Oxide Residues, Extractables & Leachables and Bioburden

Technical Regulatory Synopsis

Satvam Research provides specialized analytical and microbiological testing for medical device manufacturers, polymer converters, and pharmaceutical packaging suppliers. In compliance with ISO 10993, USP <1663>, and USP <1664>, our laboratory tests for residual Ethylene Oxide (ETO) and Ethylene Chlorohydrin (ECH) by headspace GC, Extractables & Leachables (E&L), and package bioburden.

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Sector Testing Profile

Medical Devices & Packaging Highlights

Turnaround Time (TAT)
Standard: 4 – 6 Days | Express: 72 Hours
Compliance Standards
ISO 10993-7 (Biological Evaluation of Medical Devices - ETO Sterilization), ISO 11737-1 (Sterilization of Medical Devices - Bioburden), USP <1663> & <1664> (Extractables and Leachables Guidance), USP <381> (Elastomeric Closures for Injections), USP <661> (Plastic Packaging Systems and Materials of Construction)
Testing Facility
8,500 Sq. Ft. Lab, NH-48 Vapi (Gujarat)
Data Integrity
21 CFR Part 11 Audit Trail & cGLP System
Quality Management & Monographs

Meeting Global Standards in Medical Devices & Packaging

Medical devices, catheters, syringes, rubber closures, and primary blister packaging have direct contact with drugs and patient tissue. Ensuring that manufacturing sterilants (like ethylene oxide) and container-closure additives do not leach toxic compounds is critical for global regulatory approval.

Key Governing Specifications & Pharmacopoeias

ISO 10993-7 (Biological Evaluation of Medical Devices - ETO Sterilization)ISO 11737-1 (Sterilization of Medical Devices - Bioburden)USP <1663> & <1664> (Extractables and Leachables Guidance)USP <381> (Elastomeric Closures for Injections)USP <661> (Plastic Packaging Systems and Materials of Construction)
Zero Observation
Quality Audit Trail Standard

Every test certificate (CoA) issued by Satvam Research undergoes dual-level scientific validation with complete electronic record archives.

Validated Analytical Protocols
Annual Calibrated Equipment
NIST Traceable Standards
Core Service Integrations

Applicable Testing Services for Medical Devices & Packaging

Direct access to our dedicated analytical workflows configured for this vertical.

cGLP Protocol
01

Extractables & Leachables Studies (E&L)

Controlled extraction and migration profiling per USP <1663> and <1664>.

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cGLP Protocol
02

Residual Solvent Analysis (GC-HS)

Residual ETO and ECH determination per ISO 10993-7 using headspace gas chromatography.

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cGLP Protocol
03

Cleanroom Microbiology (MLT)

Bioburden quantification on medical device surfaces per ISO 11737-1.

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cGLP Protocol
04

Physico-Chemical Characterization

FTIR polymeric identification, non-volatile residue, and heavy metal extraction.

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Full Analytical Scope

Comprehensive Parameter Testing Menu

Each discipline is executed on calibrated instrumentation under rigid quality management protocols.

1

Sterilant Residues

  • Residual Ethylene Oxide (ETO) by Headspace GC
  • Ethylene Chlorohydrin (ECH) Determination
  • Ethylene Glycol (EG) Impurity Quantification
2

Container-Closure & Polymer Extraction

  • Controlled Extraction under Acidic, Basic & Organic Conditions
  • Non-Volatile Residue & Total Organic Carbon (TOC)
  • Polymeric Identification by FTIR ATR Spectroscopy
  • Extractable Heavy Metals by ICP-OES
3

Microbial & Bioburden Quality

  • Pre-Sterilization Bioburden Estimation (ISO 11737-1)
  • Sterility Verification Protocols
  • Bacterial Endotoxin Levels (LAL Method)
Facility Infrastructure

Instrumentation Configured for Medical Devices & Packaging

Shimadzu GC-2010 Pro with Headspace Auto-Sampler
Shimadzu Prominence HPLC with PDA Detector
Lab India ICP-OES 2100
Shimadzu FTIR Spectrophotometer
Class 10,000 Cleanroom Microbiology Isolation Suite
Technical FAQ

Frequently Asked Technical Questions

Regulatory guidelines, turnaround times, and sample handling for Medical Devices & Packaging

QHow is residual Ethylene Oxide (ETO) extracted from medical devices?

In accordance with ISO 10993-7, we perform either exhaustive thermal headspace extraction or simulated-use liquid extraction, quantifying ETO and ECH against certified analytical standards.

QWhat packaging materials can be evaluated under USP <661>?

We test high-density polyethylene (HDPE), polypropylene (PP), polyethylene terephthalate (PET), and elastomeric rubber stoppers for physicochemical characterization and biocompatibility.

Direct Lab Access • Vapi Gujarat

Ready to Initiate Medical Devices & Packaging Testing?

Submit your sample parameters or request a formal quotation tailored to your batch volume and compendial requirements.

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