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Ampoule Filling Machine

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

Name

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

Brand Name:	Lingyao
Model Number:	LYAPL1-20-I
MOQ:	1 unit
Price:	USD 150,000-350,000 per unit
Payment Terms:	D/A,D/P,T/T,Western Union,MoneyGram
Supply Ability:	1 unit per month

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

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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