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GMP Certified Ampoule Filling Machine

GMP Certified Ampoule Filling Machine

Brand Name:	Lingyao
Model Number:	LYAPL1-20-I
MOQ:	1 unit
Price:	USD 150,000-350,000 per unit
Delivery Time:	180 work days
Payment Terms:	D/A,D/P,T/T,Western Union,

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

CE, ISO, GMP

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

Packaging Details:

carton, wood carton, pallets

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

GMP Certified Ampoule Filling Machine 0

GMP Certified Ampoule Filling Machine 1

GMP Certified Ampoule Filling Machine 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.

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products details

GMP Certified Ampoule Filling Machine

ampoule and vial filling machine

vial sealing machine

Automatic Ampoule Filling Line for Collagen Regenerator Solution, High Speed Filling Line for 1-20ml Ampoules, GMP Compliance

Nitrogen Purging Ampoule Sealer for Oxygen Sensitive Biologics 1-10ml， High Capacity with Isolator and Nitrile Rubber Gloves