Instructions for Washed Sterile Glass Vials
1. What are Washed Sterile Glass Vials?
Washed Sterile Glass Vials(RTU vials) is a kind of packaging containers after special process (such as dry heat sterilization, ethylene oxide sterilization, irradiation sterilization, etc.), the factory has reached the aseptic state, the user does not need to wash can be used directly. Commonly used in pharmaceutical, medical, laboratory, food, beauty and cosmetic industries for storing sterile liquids, vaccines, sterile powdered drugs, culture media, reagents and so on.
Packed in a double-layer Tyvek material bags closure to ensure sterility. Valid for three years.
2. Common Application Scenarios
- Pharmaceutical: targeted therapeutic drugs, high-value biopharmaceuticals, radiopharmaceuticals, vaccines, sterile pharmaceutical liquid dispensing, water for injection, oral liquids, etc.
- Medical: used in conjunction with specific medical devices.
- Laboratory: sterile reagents, cell culture, PCR reagents, standard solution storage, etc.
- Cosmetics: sterile injectable beauty products, sterile serums, etc.
- Food & Beverage: High-end beverages.
3. Core features
- Ready-to-use: no need to wash and sterilize, saving time and labor.
- Aseptic assurance: conforms to relevant standards (ISO13485, ISO15378, ISO11135, ISO8362, GMP, Pharmacopoeia) to ensure no microbial contamination.
- Sealability: can be sealed with rubber stoppers and aluminum seals for later use.
- Flexibility: allows pharmaceutical companies to use a small footprint and flexible filling.
- Efficiency: shortens the changeover time and increases the efficient use of the production line.
- Low investment: reduce capital investment, small scale.
4. Core quality requirements
- Insoluble particles: the number of particles greater than or equal to 10μm should not be more than 60/vial; the number of particles greater than or equal to 25μm should not be more than 6/vial (internal standard of Youlyy Industrial Co., Ltd.)
- Bacterial endotoxin: should be <0.25EU/mL
- Ethylene oxide residue: should be <1μg/mL (ISO11135)
- Pyrogen: None
5. Precautions for use ofWashed Sterile Glass Vials
- Pre-opening inspection: Make sure the package is intact and undamaged, the sterilization mark is valid, and the product is within the expiration date.
- Avoid contamination: after opening the package, it is recommended to use it up at one time, if it needs to be used several times, it should be operated in a sterile environment (e.g. ultra-clean table).
- Storage conditions: need to be protected from light, dry storage (storage environment in line with GMP norms).
- Material compatibility: strong acid, strong alkali, ultra-low temperature freeze-drying (e.g. -80℃) or organic solvents are suitable or not, to do experiments to verify in advance.
We specialize in the production of sterile glass vials,welcome customers to consult and cooperate.
