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WHITE PAPERS & CASE STUDIES

  • Comparative Human <em>in-vivo</em> Study Of An Immediate Release Tablet Over-Encapsulated By Gelatin And Hydroxypropyl Methyl Cellulose Capsules – Impact Of Dissolution Rate On Bioequivalence
    Comparative Human in-vivo Study Of An Immediate Release Tablet Over-Encapsulated By Gelatin And Hydroxypropyl Methyl Cellulose Capsules – Impact Of Dissolution Rate On Bioequivalence

    Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.

  • Why Change Is Inevitable In Aseptic Manufacturing
    Why Change Is Inevitable In Aseptic Manufacturing

    The new era of the pharmaceutical industry has been facing expiring patents and a consequent increase in R&D expenditure addressing also a rapidly growing demand for anti-cancer drugs.

  • Aging Facilities In Pharma: The Reality And Rising Concern
    Aging Facilities In Pharma: The Reality And Rising Concern

    Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered.

  • A Simple, Quick Way To Measure Bulk Strength In Small Quantities
    A Simple, Quick Way To Measure Bulk Strength In Small Quantities

    Unconfined yield strength (bulk strength) is the major principle stress that will cause material in an unconfined state to fail in shear. It is the primary flow property that governs the development of hang-ups in process equipment. It is used to compute critical arching and rathole dimensions for a given material in a hopper or bin.

  • Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form
    Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form

    As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.

  • Systems Engineering For Complex Portable Medical Device Development
    Systems Engineering For Complex Portable Medical Device Development

    As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount.

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PRODUCTS & SERVICES

Pharmaceutical Manufacturing Maintenance And Installation Services Pharmaceutical Manufacturing Maintenance And Installation Services

With our extensive range of service on offer, our customers are able to extend the life-cycle of their facilities. The scope spans from installation and hook-up, Fab-to-Fab relocation all the way through to facility management, O+M contracting for building services and energy management.

Pharmaceutical Manufacturing Consulting And Planning Services Pharmaceutical Manufacturing Consulting And Planning Services

For decades M+W Group has been providing consultancy and planning services to customers based on their needs and industry-specific requirements.

Quality Control Of Gaseous Media Quality Control Of Gaseous Media

Pure gases are used in many fabrication processes in the semiconductor, LED, flat panel and optical industry. They are used as purging gases for cleaning and setting up inert atmospheres, dilution and carrier gas, reaction gases and pneumatic drives. For most processes pure and ultrapure qualities are required.

Pharmaceutical Manufacturing Construction And Project Management Services Pharmaceutical Manufacturing Construction And Project Management Services

Our target is to provide our customers with complete solutions and the realization of a project – be it an Engineering, Procurement, Construction (EPC) or an Engineering, Procurement, Construction Management (EPCM) solution. Further to design, construction and commercial management this includes site safety management, cost control, scheduling, contractor supervision, start-up and commissioning, as-built documentation and warranty management.

Pharmaceutical Manufacturing Design And Engineering Services Pharmaceutical Manufacturing Design And Engineering Services

M+W Group’s global engineering network provides our customers with world class experience in project planning and design for all engineering disciplines, from architecture to process systems.

Chemical Filter Testing Chemical Filter Testing

Chemical filters are used in a wide variety of applications for the contamination control of ambient and circulating air. Monitoring and filtration are usually done in the ppb range. The laboratory of M+W Products offers comprehensive service for testing new as well as proofing of chemical filter materials that have to meet the highest quality requirements. The development of filter materials is focused on removal of all kinds of acidic, basic and organic substances.

Air Quality Testing Air Quality Testing

Reducing all kinds of air contamination is a main goal in manufacturing of contamination-sensitive products like wafers, optics, lasers and processes like extreme ultraviolet (EUV) lithography.

Ultrapure Water (UPW) Ultrapure Water (UPW) Ultrapure Water (UPW) Ultrapure Water (UPW)

The process and the product quality can be affected by contaminated rinsing water that contains different organic and inorganic contaminants. By integrating all technologies for water purification, the purity of water is upgraded to an ultra-high level by removing particles, organic and inorganic components as well as gases that are dissolved. The semiconductor industry requires increasingly stringent tolerance limits for contaminants in ultrapure water, especially for critical metals and TOC (see ITRS). This demands a carefully structured, analytical test program for critical parameters like ions, metals, particles, organic compounds and bacteria in order to ensure a high quality of UPW

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