2ml 3ml 5ml 10ml 30ml Washed Sterile Depyrogenated Ready To Use Type I Neutral Borosilicate Glass Bottle Vial

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Product Overview

Description


2ml 3ml 5ml 10ml 30ml Washed Sterile Depyrogenated


Ready To Use Type I Neutral Borosilicate Glass Bottle Vial


 



Product Description


 


















































Product Name



Sterile Glass Vial



Material



Neutral borosilicate glass



Color



Clear and Amber



Production environment



Class A / ISO 4.8-class clean room



Features



Injection water washed, Sterile, Depyrogenated



Executive standard



ISO8362, ISO11135, ISO11040, ISO14644, ISO15378, ISO9001


meet the requirements of E.U. Pharmacopoeia and U.S. Pharmacopoeia



Capacity



2ml-30ml



Mouth Shape



Crimp Neck



Mouth Size



13mm 20mm



MOQ



5000 pcs



Packaging



PP box or nest tray, tyvek bag, carton, pallet



 


 


Sterile vial picture:

7488ml3 


 


 


Advantages of sterile depyrogenated glass vial:


1, Washing with WFI , sterile with ETO, pyrogen-free / depyrogenated, ready-to-use


2, Insoluble Particles are controlled; Sub-visible particles are controlled;


    Bacterial endotoxins are controlled.


3, type I neutral borosilicate glass, the physical and chemical properties are good.


4, safe nest tray for transport, storage


5, high quality, high efficiency for filling lines


 





Certificate


2023-10-19 





Company Information


    Shandong Yihua Pharma Pack Co., Ltd. from Shandong Province, China, devoting safe and reliable pharmaceutical packaging products and has more than 18 years of exporting experience.


    Yihua Pharma Pack specializes in researching, developing and producing pharmaceutical products. The main products have pharma glass vials, glass ampoules, glass test tubes, borosilicate glass tubings, glass pre-filled syringes, flip off caps, aluminum seals, pharma rubber stoppers.


    In Yihua Pharma Pack company team, We spent the majority of our career in pharmaceutical packagings where we developed a deep understanding of the requirements necessary to productive process and quality control system by GMP standard. Yihua have ISO15378, CE, SFDA, ISO9001, ISO14001 certificates.


    Yihua always provide customers with high-quality service, professional, high efficiency, responsible is our service core.



Class A and ISO 4.8-class clean room





Quality Control


We strictly control raw materials, production process, semi-finished products, finished products and other process to ensure stable and reliable product quality.


1. We have established a perfect quality management system


    We fully implements the ISO15378:2017 quality management system, and formulates a full set of working standards, production standards and recording standards, established enterprise internal control standards higher than ISO standards.


2. We use the on-line automatic inspection system


    We have installed advanced fully automatic light sense inspection equipment on the production line to inspect all products automated to avoid the instability of inspector inspection.


3. Complete test and inspection ability


    The company has a complete set of advanced laboratory testing instruments, which can be used for testing of standard requests.


4. Advanced and efficient production equipment


    Our production equipments are high precision and high efficiency.


5. Independent quality management department


    Quality management department strictly control raw materials, production process, semi-finished products, finished products and other process, training and guide all employees in accordance with the GMP requests for production.


6. Raw material supply chain management


    We select suppliers strictly in accordance with the requirements of ISO15378:2017.


7. Retention sample management


    We have a professional sample retention room, and has a perfect management system, we store up the samples for every batch and every order.


8. Comprehensive training system


    We have detailed training plans and training courses for employees in different positions, different job contents, different operating methods, various quality problems, customer complaints, etc.


 


Online Automatic Inspection Equipment


 





Production process


 





Packaging & Shipping


Packing



 


 


PP


 


 


Shipping


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