How to Qualify Single-Use Bags – Extractables, Leachables & Certification
Single-Use Bags are critical in modern bioprocessing – used for media storage, mixing, freezing, and transport.
But not all bags are created equal. To ensure reliability and regulatory compliance, qualification is essential.
This includes extractables & leachables (E&L) testing, certification levels, and full documentation.
At SeamlessBio, we deliver bags that meet these requirements – so your QA teams can trust every batch.
Why Qualification Matters
- Regulatory compliance – meeting FDA, EMA and pharmacopeia standards
- Product safety – preventing contamination or unexpected interactions
- Reproducibility – ensuring consistent results across batches and sites
- Risk mitigation – avoiding delays and costly failures in scale-up
Qualification is not just a box to tick – it’s the foundation of reliable bioprocessing.
Extractables & Leachables (E&L) Testing
🔬 What are Extractables?
Compounds that may be released from bag materials under extreme conditions (heat, solvents, stress).
🔬 What are Leachables?
Compounds that actually migrate into your media or product under real process conditions.
🧪 Why E&L Testing Matters
- Ensures bag material compatibility
- Prevents interference with cell growth, antibody production, or vaccine stability
- Provides data for regulatory filings
At SeamlessBio, our single-use bags are tested according to ASTM and USP <665>/<1665> standards – providing full E&L profiles for QA and regulatory teams.
Certification Levels for Single-Use Bags
To simplify qualification, many suppliers define certification levels:
- Gold Level – Full E&L package, validated sterility & endotoxin, detailed documentation
- Silver Level – Core documentation (COA, COO, MSDS) + sterility tests
- Bronze Level – Standard product documentation, suitable for less critical processes
At SeamlessBio, we adapt to your needs:
👉 From basic R&D supply to fully certified bags for GMP production.
SeamlessBio’s Approach to Qualification
Our Single-Use Bags are supplied with:
✅ cGMP & ISO 9001/13485 certification
✅ Full documentation: COA, COO, MSDS
✅ E&L testing data upon request
✅ Sterility & endotoxin reports
✅ Custom packaging & volumes
This makes qualification straightforward for QA, regulatory, and production teams.
Applications of Qualified Bags
- Vaccine & viral vector manufacturing
- Monoclonal antibody (mAb) production
- Cell & gene therapy workflows
- Diagnostics & buffer storage
- Regenerative medicine bioprocessing
Request Your Qualified Single-Use Bags Today
SeamlessBio is your partner for qualified single-use bags – with extractables & leachables testing, certification levels, and full documentation.
📩 Contact us to request your datasheet, E&L report, or quote today.
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