Peristaltic Pump for
Aseptic Final Fill —
Continuous, Sterile, Logged
Aseptic filling lines shouldn’t stop for a tubing swap. BioDuo® dual‑head peristaltic pumps keep sterile media flowing with instant switchover (≤2 s), so vials, syringes and bags are filled without downtime or contamination risk. Built in Maharashtra under ISO 13485 with GMP‑ready materials, BioDuo supports 21 CFR Part 11 event logging and covers 0.005–3.5 L/min for dosing and transfer. Choose your flow range and sterility level; we’ll recommend the model and tubing that fit.
Why BioDuo for Aseptic Filling
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Zero downtime: Dual‑head architecture enables seamless head‑to‑head switchover in ≤2 s.
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Sterility by design: SS316L enclosures, smooth surfaces, and VHP/cleanroom compatibility.
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Data you can trust: 21 CFR 11‑style user logins, time‑stamped events, and audit trails.
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Precision & range: From microliters per minute to liters per minute with consistent, ripple‑reduced flow.
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Made in India: ISO 13485 manufacturing in Ambernath; fast lead times and local service.
Typical Use Cases
Final fill for vials, pre‑filled syringes and IV bags | Media/buffer dosing into aseptic manifolds | Transfer from formulation tank to filling isolator
Recommended Models & Flow Ranges
BioDuo Micro
0.005–120 mL/min
Precise low‑flow dosing for development and clinical lots.
BioDuo 3.5 L Series
0.5–3.5 L/min
High‑throughput final fill and buffer transfer for commercial lines.
Tubing IDs (examples):
0.8 / 1.6 / 2.4 / 3.2 / 4.8 / 6.4 mm (others available)
Compliance add‑ons:
IQ/OQ templates, validation pack, and SOP checklist on request.
Compliance & Validation
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Certificates: ISO 13485, materials traceability, ZED, GMP compliant.
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Audit: Role‑based access, password policies, time‑stamped events.
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Cleaning: Wipe‑down SS316L; compatible with common cleanroom protocols
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Docs for QA:
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Certificate Pack (.pdf)
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IQ/OQ plan
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URS checklist for aseptic filling pumps
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Mini Specification Table
Model | Flow Range | RPM Range | Switchover | Material |
|---|---|---|---|---|
BioDuo Micro | 0.005–120 mL/min | 0.1–200 rpm | ≤2 s | Carbon Composite Body |
BioDuo 2L | 0.5-2000 L/min | 0.1-200 rpm | ≤2 s | Carbon Composite Body |
BioDuo 3.5L | 0.5–3.5 L/min | 0.1–375 rpm | ≤2 s | Carbon Composite Body |
BioDuo Pro 2L | 0.5-2000 L/min | 0.1-200 rpm | ≤2 s | SS316L / cleanroom‑ready |
BioDuo Pro 4L | 75-4000 L/min | 15-400 rpm | ≤2 s | SS316L / cleanroom‑ready |
BioDuo Pro 18L | 0.2-18000 L/min | 0.1-600 rpm | ≤2 s | SS316L / cleanroom‑ready |
BioDuo Pro FLP 2L | 0.5-2000 L/min | 0.1-200 rpm | - | SS316L / cleanroom‑ready |
Implementation Diagram
Formulation Tank
BioDuo (Dual‑Head)
Filling Isolator
FAQs
Q1. How does dual‑head switchover keep lines running?
A. When the active head approaches tubing wear limits, the standby head takes over in ≤2 seconds. Operators swap tubing on the idle head without stopping the line.
Q2. Can the pump log events for 21 CFR Part 11 compliance?
A. Yes. BioDuo supports user‑level access, password rules and time‑stamped events; logs can be exported for audits.
Q3. Is it cleanroom and VHP compatible?
A. Yes—SS316L construction and hygienic design support common cleanroom wipe‑downs and VHP routines.
Q4. Which tubing ID should I choose?
A. It depends on your target flow and viscosity. Use our selector/RFQ and we’ll specify the ID and RPM window.
Q5. What are typical lead times in India?
A. Standard configurations ship in 2.4 weeks ex.factory (Maharashtra). Urgent projects can be prioritized; ask our team.