USP VI Ultra Single Use 3-layer Double Bag Sampler Company

SteriWare disposable double bagged USP VI sterile dust-free spoonSteriWare Double Bag Disposable - USP Grade VI SpoonDouble Bagged - USP Class VI Spoon

These sterile spoons are commonly used in the manufacturing and sampling of cosmetics, food, and pharmaceuticals.

Easy to use

The spoon is designed to be used directly from the bag. Double bag means that the outer bag can be removed when entering the clean room to ensure cleanliness in the clean room or manufacturing area.

• quality-Made of food grade HDPE that meets FDA and EC standards. HDPE has good chemical resistance and can be easily recycled. The funnel is sterilized by gamma irradiation.
  
  

• USP Grade VI-high qualitymedicineGrade polymer has also passed independent testing under USP 661. Please discuss with us the testing of non pyrogenic endotoxins.
  
  

• Clean room manufacturing-Ultra double bagged spoons are manufactured under cleanroom conditions and ultimately packaged in a Class 10000 cleanroom. Each spoon undergoes inspection before packaging
  
  

• Fast delivery-Over 1 million inventory items can be delivered to most parts of the world via express delivery within 1-2 days
  
  

• Shop with confidence-Over 100000 satisfied customers

SteriWare disposable double bagged USP VI sterile dust-free spoonSteriWare Double Bag Disposable - USP Grade VI SpoonDouble Bagged - USP Class VI Spoon

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The dual bag USP VI grade disposable sterile sampler has brought many benefits and conveniences to laboratory and production personnel:

Assistance to laboratory personnel:

1. Aseptic operation: Provide pre sterilized samplers to ensure that laboratory personnel do not have to worry about contamination during sampling, reducing operational risks in experiments.

2. Easy to operate: The sampler is designed to be simple and easy to use, allowing laboratory personnel to quickly and efficiently collect samples, saving experimental time.

3. Ensure sample quality: By using high-quality materials and strict biocompatibility standards, the sampler is guaranteed not to release harmful substances, thereby ensuring the quality and reliability of the sample.

4. Compliant with regulatory requirements: Adopting USP VI certified samplers helps the laboratory comply with regulatory requirements and ensure the compliance and traceability of the experimental process.

5. Reduce operational errors: The double bag design simplifies the process of sterile equipment entering the clean room, reducing laboratory personnel's errors and contamination risks during operation.

Assistance to production personnel:

1. Ensuring product quality: Using pre sterilized samplers can ensure that the samples obtained during the production process are sterile, thereby ensuring the quality and safety of the final product.

2. Improved production efficiency: Simplified the sample collection process, saved the time and energy of production personnel, and improved production efficiency and productivity.

3. Reduce product recall risk: By ensuring the sterility and quality of samples, the recall risk caused by product contamination is reduced, protecting the reputation and interests of the enterprise.

4. Reduce waste disposal costs: Due to the use of high-quality materials and pre sterilization design in the sampler, the frequency of replacement and waste disposal costs have been reduced, saving the company's expenses.

5. Improving employee safety: Aseptic and biocompatible materials reduce the risk of production personnel coming into contact with harmful substances, enhancing workplace safety and employee health.

1. Complies with USP biocompatibility standards<87>/<88>

• USP Class VIIt is the highest level certification for material biosafety by the United States Pharmacopeia.

• Through a series of rigorous in vivo tests (such as systemic toxicity, intradermal reactions, implant tests), ensure that the material does not release harmful substances when in contact with drugs or the human body.

• It is crucial for sterile preparations, injections, cell therapy products, etc.

2. Three layer packaging design to maximize pollution prevention

• Double bag+outer protection(3 layers in total) Structure provides:

• the first layerThe inner bag directly wraps around the sampling spoon to maintain initial cleanliness;

• the second layerThe outer bag provides a secondary barrier;

• the third layer(such as hard outer boxes or tear resistant bags): Physical protection during transportation and storage.

• Effectively blocking particles, microorganisms, endotoxins, and environmental pollutants, meeting the requirementsISO 5 or higher cleanroomUsage requirements.

3. Disposable, eliminate cross contamination

• Each sampling spoon isPre sterilized, ready to use type(Usually sterilized using gamma rays or ethylene oxide);

• Avoiding the cleaning validation challenges and residual risks caused by traditional metal/reusable tools;

• Especially suitable for scenarios where multiple batches and products are produced in parallel.

4. Pure material, low precipitation, low adsorption

• Usually byHigh purity polypropylene (PP) or polytetrafluoroethylene (PTFE)make;

• Extremely low extractables and leachables;

• Not adsorbing active ingredients, ensuring sample representativeness and detection accuracy.

5. Easy to operate, in compliance with GMP standards

• Aseptic opening can be used, simplifying the sampling process;

• Designed ergonomically for easy operation in isolators or RABS;

• Support complete audit tracking (such as clear labeling of batch number, sterilization date, expiration date, etc.).

Application scenarios

• API and excipient sampling

• Material transfer before sterile preparation production

• Cell and Gene Therapy (CGT) Product Processing

• Sampling of Highly Active Pharmaceutical Ingredients (HPAPI) (requires coordination with a closed system)