Overview

• Post By : Chandan Sah


• Source: Ami Polymer Pvt Ltd


• Date: 06 Dec,2024

Introducing the Ultimate Solution for Bio-Processing Applications – Our Sterile Sampling System Crafted to ensure the highest level of integrity in your critical sampling processes, this system acts as a formidable barrier against cross-contamination. Designed to elevate sterility, it provides unparalleled protection for your operations, maintains the purity of your products, and ensures compliance with industry regulations.

With a focus on both reliability and ease of use, our sterile sampling system is the key to optimizing bio-processing workflows and safeguarding the quality of your samples every step of the way.

APPLICATIONS: –

Ensures Purity and Quality in Drug Manufacturing:

Safeguards the integrity of our products throughout the production process.

Supports Sterile Sampling in Cell Culture and Research:

Ideal for maintaining contamination-free environments in critical research and development settings.

Maintains Quality During Sample Collection:

Guarantees clean, accurate samples for reliable analysis and testing across various.

FEATURES/BENEFITS –

1. Advanced Contamination Control: Designed to eliminate the risk of cross-contamination, ensuring sample integrity.
2. Consistent Accuracy: Provides reliable, precise results for critical bio-processing applications.
3. Regulatory Compliance: Fully compliant with industry standards, ensuring safety and adherence to regulations.
4. Customizable Solutions: Flexible configurations to meet the specific needs of your process and application.
5. Easy Integration: Seamlessly fits into your existing workflows for enhanced operational efficiency.

CERTIFICATIONS:
Sterile Sampling System certified for quality and compliance to ensure optimal protection and integrity in your sampling processes.

1. Cytotoxicity as per USP
2. USP < 85> Bacterial Endotoxin
3. USP < 661.1> Extractable metals
4. USP < 788> Sub visible particulate matter
5. USP < 71> & ISO < 11737-1 Sterility assurance

Product Uses:

In a biopharmaceutical manufacturing facility, our Sterile Sampling System is used to collect samples during drug production.

The Infuflex Film 9101 bag ensures sterility, while TPE and Silicone tubing provide secure fluid transfer. The polypody and stainless-steel needle offer durability, and the silicone septum prevents contamination. This system guarantees sample purity, reduces cleaning needs, and ensures compliance with regulatory standards.

Material of Construction (MOC):

1. Bag: Infuflex Film 9101 – A high-quality, flexible film ideal for maintaining sterility and durability.
2. Tube: TPE (Thermoplastic Elastomer) and Silicone – Offers excellent flexibility and chemical resistance.
3. Body: Polypropylene – Provides strength, clarity, and impact resistance for secure, reliable performance.
4. Septum: Silicone – Ensures a tight, contamination-free seal for sample integrity.
5. Female Luer Lock: Polypropylene – A robust and chemical-resistant material that ensures a secure connection.
6. Male Luer Plug: Polypropylene – Ensures a safe, leak-proof closure for sample protection.
7. Needle: (Stainless Steel) – Known for its resistance to corrosion, offering durability in critical applications.

Author By: –

Chandan Sah

Deputy General Manager – Business development

[email protected]