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GMP Certified Ampoule Filling Machine

Name: GMP Certified Ampoule Filling Machine
Brand: Suzhou Lingyao Intelligent Equipment Co., Ltd.
SKU: LYAPL1-20-I
Price: 250.00 USD
Availability: InStock

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

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