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Suzhou Lingyao Intelligent Equipment Co., Ltd.

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Province/State:jiangsu

Country/Region:china

Contact Person:MrJerry

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

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: Lingyao
Price: 150 USD

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Brand Name :Lingyao

Model Number :LYAPL1-20-I

Certification :CE, ISO, GMP

Place of Origin :China

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

Delivery Time :180 work days

Packaging Details :carton, wood carton, pallets

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

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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

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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