Introducing Ami Polymer mixer bags are specifically designed to meet the rigorous demands of the bio-pharmaceutical and single-use disposable industries. Engineered for superior performance, these bags are offered in a variety of internal dimensions, ensuring optimal compatibility with your unique process requirements. Manufactured in a controlled environment, our mixer bags are produced in an ISO Class 7 clean room, where every step of the process, from raw material sourcing to final product output, is meticulously monitored to meet the highest quality standards.
Characteristics
- ISO Class 7 Clean Room Manufacturing: Our mixer bags are produced in a state-of-the-art, ISO Class 7 clean room, ensuring that each product meets the strictest standards of quality and sterility.
- Quality Commitment: We maintain a robust quality assurance system, fully compliant with current Good Manufacturing Practices (cGMP), so you can trust that our products meet the highest industry standards.
- Global Reach: With advanced technology and expanded facilities, we are able to provide top-tier mixing solutions to bio-pharmaceutical companies worldwide.
Features & Benefits
- Tailored to Specific Applications: Custom-designed to meet the precise needs of your process, ensuring optimal performance and reliability.
- Precision Impeller for Consistent Mixing: The advanced impeller design ensures homogeneous mixing, enhancing process efficiency and consistency.
- Built for Durability: High burst strength materials provide exceptional reliability, even under demanding conditions, ensuring long-term durability.
- 100% Integrity Testing: Each bag undergoes a rigorous pressure leak test, guaranteeing 100% integrity before use.
- Superior Protection for Product Molecules: Our mixer bags offer excellent protection for sensitive bio-pharmaceutical components, minimizing the risk of contamination or degradation.
- User-Friendly Connections: Convenient inlet and outlet connections make setup and operation easy, saving you time and effort.
Features & Benefits
APPL Mixer bags can be used in process and transfer of
- Cell Culture Media
- Process Intermediates
- Formulations
- Buffers
Precision Mixing for Bio-Pharmaceuticals: A Reliable Solution for Critical Applications
Ami Polymer mixer bags, designed to meet the exacting demands of the bio-pharmaceutical and single-use disposable industries.
For example, consider a biotech company developing a new vaccine: the precision and reliability of the mixing process is critical
to ensuring product consistency and quality. Our mixer bags, available in a variety of internal dimensions, are engineered to optimize
this process— whether it’s for large-scale cell culture or small batch production.
Manufactured in an ISO Class 7 clean room, our mixer bags undergo strict controls throughout every stage of production,
from the selection of raw materials to the final product. This level of precision guarantees that each bag meets the highest standards,
ensuring the integrity of your process and the protection of sensitive biological components.
Just as a pharmaceutical company wouldn't risk compromising the sterility of their sterile drug formulations, our mixer bags provide the same level of
assurance in bio-pharmaceutical mixing. Whether you're working with biologics, vaccines, or cell therapies, our solution is tailored to deliver optimal
results every time.
Size Available
| Size | Catalogue no. With Powder Port | Catalogue no. Without Powder port |
| 50L | 3D-MB-050L-0401 | 3D-MB-050L-0401 |
| 100L | 3D-MB-100L-0401 | 3D-MB-100L-0402 |
| 200L | 3D-MB-200L-0401 | 3D-MB-200L-0402 |
| 500L | 3D-MB-500L-0401 | 3D-MB-500L-0402 |
| 650L | 3D-MB-650L-0401 | 3D-MB-650L-0402 |
| 1000L | 3D-MB-1000L-0401 | 3D-MB-1000L-0402 |
Certifications
- ISO 117 37-1
- USP < 88 > Biological reactivity tests, In Vivo
- USP < 87 > Biological reactivity tests, In Vitro
- USP < 85 >
- USP < 788 >
- USP < 661 >
- Extractable
- US FDA 21 CFR Part 210.3 (b) (6)
- 100% Integrity tested
Leave a Reply
Your email address will not be published.