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

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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

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

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

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

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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