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FEATURED ARTICLES

  • Quality Takes Center Stage At ISPE Event
    Quality Takes Center Stage At ISPE Event

    As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. If you take a look at the ISPE/FDA/PQRI Quality Manufacturing Conference agenda, attendees will see this is an opportunity to learn how to accomplish just that. 

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WHITE PAPERS & CASE STUDIES

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PRODUCTS & SERVICES

Logistics Audit/Assessment & Engineering Solution Services

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

Integrity Mixers

Integrity Mixers

Integrity™ branded products are made from the same TK8 film so all product-contact areas are identical. This approach simplifies qualification and validation efforts and reduces overall costs. ATMI's Integrity Mixing Systems have the broadest range of flexible, single-use mixing systems. They can contain solid/liquid  and liquid/liquid mixing solutions with mixing volumes scalable up to 2000L. The single-use systems eliminate non-value-added cleaning and eliminate cross-contamination risk.

Integrity Bioreactors

Integrity Bioreactors

Integrity™ Bioreactors are scalable, ergonomic and modular systems with very low shear mixing. Integrity Bioreactors keep control of all process parameters ensuring customized culture conditions, and they are carefully adapted for cultivation of suspension and adherent cells at very high densities. There is no need for CIP/SIP, and can help avoid cross-contamination risks. Integrity™ branded products are made from the same TK8 film so all product-contact areas are identical. This approach simplifies qualification and validation efforts and reduces overall costs.

Newform, Medical Grade Packaging

Newform, Medical Grade Packaging

In the fast growing Biopharma market, the need for ultra clean sterile packaging is growing at a high speed, often driven by regulatory authorities and cGMP regulations.

Eliminating every risk of delivering a contaminated parenteral drug that might be hazardous to a patient's health or even his life is the key concern that drives these regulations. With our Newform™ product line, we respond to this need by producing cleanroom packaging that meets these ever growing requirements.

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