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Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy
  • Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy

Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy

Product Details:
Place of Origin: China
Brand Name: Lingyao
Certification: CE, ISO, GMP
Model Number: LYAPL1-20-I
Document: 1-20ml ampoule washing, dry...ao.pdf
Detail Information
Place of Origin:
China
Brand Name:
Lingyao
Certification:
CE, ISO, GMP
Model Number:
LYAPL1-20-I
Document:
1-20ml ampoule washing, dry...ao.pdf
Machine Name:
Ampoule Filling Sealing Machine
Function:
Washing, Sterilization, Filling, Sealing
Filling Volume:
1-20ml
Filling Liquid Type:
Pharmaceutical Injectable Solutions
Output Capacity:
8000-30,000 BPH
Ampoules Material:
Glass
Filling Accuracy:
+/-0.5%
Breakage Rate:
<0.5%
Purging Air:
Nitrogen
LAF System:
ISO Class A
Oven Sterilization Style:
Dry Heating
Pump:
Peristaltic/Piston(as Request)
Sealing Gas:
Natrual Gas, Hydrogen-oxygen Gas
Garuantee:
3 Years
Trading Information
Minimum Order Quantity:
1 unit
Price:
USD 150,000-350,000 per unit
Packaging Details:
carton, wood carton, pallets
Delivery Time:
180 work days
Payment Terms:
D/A,D/P,T/T,Western Union,MoneyGram
Supply Ability:
1 unit per month
Product Description

Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy


Precision Engineered for High-Risk Analgesic Formulations

⚙️ Key Differentiators vs Competitors
✅ Endotoxin-Free Sterility

  • Combines ultrasonic cleaning (99% particulate removal) and dry heat sterilization (300°C/5min) to achieve SAL ≤10⁻⁶, critical for opioid-free analgesics.
  • Nitrogen-protected filling chamber prevents oxidation of NSAIDs (e.g., ketorolac tromethamine).

✅ Micro-Dose Precision

  • Peristaltic pump system with ±0.5% volumetric accuracy, ensuring consistency in low-volume formulations (1-20ml ampoules) for epidural/parenteral analgesia .

✅ Anti-Counterfeiting Traceability

  • Integrated QR code tracking from raw material to batch release, compliant with FDA DSCSA requirements for controlled substance tracking.

Technical Parameters Table

Parameter LYAPL1-20 Specs Industry Standard
Capacity 8,000-3,0000 ampoules/hour 3,000-6,000 ampoules/hour
Dosing Accuracy ±0.5% (1-20ml range) ±1.5%
Sterilization Temperature 350°C (max) 250-280°C
Airflow Cleanliness Class 100 (ISO 5) Class 10,000 (ISO 8)
Changeover Time ≤15min (modular tooling) 45-60min

Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy 0

Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy 1

Ampoule Filling Sealing Machine GMP Certified Sterile Processing Line For Analgesic Injections With High Dosing Accuracy 2

Target Applications

  • Non-Opioid Pain Management: High-precision filling of capsaicin-based neuropathic pain solutions.
  • Postoperative Analgesics: Aseptic production of ropivacaine/bupivacaine ampoules for nerve blocks.
  • Migraine Therapies: Oxygen-sensitive triptan formulations (e.g., sumatriptan) with nitrogen shielding.

Certifications

  • GMP, ISO 13485, and FDA 21 CFR Part 11 compliance .
  • Validated per EMA Annex 1 guidelines for sterile medicinal products.

Why Suzhou Lingyao?

  • 8+ years specializing in controlled substance production equipment .
  • Customizable CIP/SIP systems for Schedule II-V drug manufacturing compliance.

Tags:

ampoule and vial filling machine,

vial sealing machine

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