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Business

Leading the Way in the Bioindustry, BIOSREAM

헬스케어

TEST & ANALYSIS SERVICE

Since its establishment in 2022, Biostream Test & Analysis Center has conducted quality inspection tests on domestically licensed pharmaceutical raw
materials and finished products based on the Korean Pharmacopoeia. All employees are dedicated to achieving designation as a "Drug Testing and
Inspection Institution" by the Ministry of Food and Drug Safety to ensure the reliability of test results.

We aim to become the leading pharmaceutical analysis center in the Republic of Korea by continuously investing in R&D based on customer requirements.
We are introducing advanced equipment such as isolators, LC, and GC and plan to establish an analysis system that aligns with global trends.

Additionally, we will establish Data Integrity-based testing methodologies suitable for cutting-edge analytical instruments by leveraging our extensive
knowledge and superior technology. Through these efforts, we will position ourselves as the top testing institution in Korea with international competitiveness.

Services

Pharmaceutical Quality Inspection Services
  • Conduct quality inspection tests on domestically licensed pharmaceutical
    raw materials and finished products, issuing internal certificates.
  • Provide comprehensive quality control services.
  • Perform Analytical Method Transfer between companies.
  • Conduct services in compliance with the KFDA's regulations on testing
    and inspection organizations (operation of testing and inspection organizations
    including quality management system, management of facilities and
    equipment including laboratory safety management, conducting tests
    and inspections including sample management, maintaining traceability, etc.)
Development of Test Optimization Methods
  • Development of method validation
  • Verification of testing time and efficacy
  • Optimization of Lab. budget

Test Formulations and Test Items

Test
Formulations

Other Solids
Preparations
  • Suppositories
  • Vaginal tablets
Semi-Solid
Preparations
  • Gels
  • Ointments
  • Liniments
  • Paste
Injections or
Irrigations, Dialysis
Solutions
Eye Ointment
Collyrium

Test Items

Conduct tests in accordance
with the Korean and International
Pharmacopeia and Biologics
Standards and Test Methods.

Default Designated Tests
  • Loss on Ignition Test Method
  • Residue on Ignition Test Method
  • Loss on Drying Test Method
  • pH Measurement Method
  • Uniformity of Dosage Unit Test
    Method
  • Tests for Volume of Injections
  • Tests for Metallic Particles
  • Tests for Insoluble Substances
Pharmacopeia Tests
  • Microbial Limit Test
  • Sterility Test - Rigid Isolator
  • Endotoxin Test - LAL and rFC
    method
  • Mass and Volume Testing Method
  • Insoluble Particulate Matter Test
    for Eye Drops
  • Insoluble Particulate Matter Test
    for Injectables
  • Microbiological Titration Test
    for Antibiotics
Biologics Tests
  • TB (Tubercular Bacillus) Negative Test
  • Mycoplasma Negative Test
  • Electrophoresis

Workflow

  1. Step.01
    Test Consultations
    and Inquiries
  2. Step.02
    Provide
    a Quote
  3. Step.03
    Enter into
    a Contract
  4. Step.04
    Proceed with
    the Service
  5. Step.05
    Check the
    Results
  6. Step.06
    Issue Test
    Reports
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