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{"title":"Aseptic Ampoule Filling Line for Sensitive Biologics EU-GMP Certified, 99.9%","imgUrl":"https:\/\/img.silkroadsl.com\/nimg\/b6\/0b\/cfa9b3cf77b13248065b2d5bca60-200x200-1\/aseptic_ampoule_filling_line_for_sensitive_biologics_eu_gmp_certified_2c_99_9_25_sterility_assurance_2c_0_5_25_precision.jpg","attrs":{"Brand Name":"Lingyao","Model Number":"LYAPL1-20-I","Certification":"CE, ISO, GMP","Place of Origin":"China"}}
{"title":"Aseptic Ampoule Filling Line for High Precision Vaccine and Biologics EU GMP","imgUrl":"https:\/\/img.silkroadsl.com\/nimg\/9a\/9f\/ceb47f1ad9a217ebbd7055e21808-200x200-1\/aseptic_ampoule_filling_line_for_high_precision_vaccine_and_biologics_eu_gmp_compliant_2c_99_9_25_sterility_assurance.jpg","attrs":{"Brand Name":"","Model Number":"LYAPL1-20-I","Certification":"CE, ISO, GMP","Place of Origin":"China"}}
{"title":"Ampoule Filling Line for High Temperature Environments FDA Compliant and 26","imgUrl":"https:\/\/img.silkroadsl.com\/nimg\/b5\/74\/cb149c0a306e671ea9c5d5b3b543-200x200-1\/ampoule_filling_line_for_high_temperature_environments_fda_compliant_and_26_2c000bph_capacity.jpg","attrs":{"Brand Name":"Lingyao","Model Number":"LYAPL1-20","Certification":"CE, ISO, GMP","Place of Origin":"China"}}
Ampoule Filling and Sealing Machine Suitable for 1-10ml Glass Ampoules with Nitrogen-Purging Capability
The ampoule filling and sealing machine is designed for 1-10ml glass ampoules and supports nitrogen-purging during the filling process. Its main features include:
Pharmaceutical-Grade Sterility Assurance
Class 100 cleanroom standards: Triple air filtration system with microbial load control achieving SAL≤10⁻⁶ (viral inactivation level).
Comprehensive contamination control: Ultrasonic deep cleaning + 300℃ dry heat sterilization + nitrogen protection capping, compliant with EMA/FDA sterility requirements.
International Value: Directly suitable for production standards of regenerative medicine products in Europe and the USA.
High-Precision Filling with Flexible Production
±0.5% dosing error control: Servo-driven piston pump with real-time dosage adjustment via touchscreen, ensuring consistency for high-value products like collagen/peptide solutions.
Modular quick-change capabilities: Universal production line for 1-10ml ampoules, enabling 30-minute switches for varying formulations like hyaluronic acid gels/freeze-dried collagen powders.
International Value: Meets the custom demand of small batch production in the aesthetic medical industry (e.g., regional formulation adjustments).
Global Compliance Certification Coverage
Triple certification backing: Compliant with GMP, ISO 13485, and FDA 21 CFR Part 11, supporting electronic batch records (aligned with European audit trail requirements).
EMA virus inactivation verification: Documentation supporting SAL≤10⁻⁶ validation reports accelerates the overseas registration of biological products.
Specifications
Weight
1500KG
Dimensions
5000mm L x 2000mm W x 1950mm H
Total Power
35KW
Voltage/Frequency
380V/50Hz
Filling Method
Stainless Steel Pump or Peristaltic Pump (customizable)
Intelligent and Traceability System
End-to-end traceability system: PLC-controlled QR code tracking from raw materials to packaging, ensuring full traceability.
Remote operational support: Multi-language interface (English/German/Spanish) and IoT fault diagnostics, reducing downtime risks for international clients.
Lifecycle Cost Advantages
Energy-efficient design: Nitrogen consumption reduced by 40% compared to traditional nitrogen equipment; dry heat sterilization energy usage optimized by 30%.
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2013
Total Annual:
5,000,000-10,000,000
Employee Number:
50~200
Ecer Certification:
Verified Supplier
Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling... Established in 2013, Suzhou Lingyao Intelligent Equipment Co., Ltd. has a strong reputation for providing innovative and reliable solutions to meet the diverse needs of companies. The company's product range includes a wide variety of equipment such as intelligent filling machines, labeling...