GMP Archives - Medical Design Sourcing

Outsourcing single-use technologies to accelerate speed to market

To fast-track the time to market and gain a competitive edge, pharmaceutical development companies are increasingly implementing single-use technologies (SUT). Single-use technologies are built using an array of components, including sampling bottles, filters, Luer locks, seals and dispensing tips. The technology can be as simple as a single assembly. Or it can be an entire system made up of multiple complex assemblies used across the entire manufacturing process, including formulation, upstream/downstream processing and final product filling.

SUT offers many benefits compared to traditional stainless-steel systems, such as eliminating clean-in-place or steam-in-place (CIP/SIP) requirements, faster changeovers between batches resulting in reduced production time, more flexible infrastructure, and a decreased risk of cross-contamination.

Although standard, off-the-shelf SUT assemblies are currently available, most narrowly focus on upstream processes that use ki…

Using RVI to prevent contamination and maintain purity of pharmaceuticals

How remote visual inspection (RVI) can help pharma companies prevent contamination and maintain product-line purity requirements.

Drug manufacturers use a combination of indirect and direct quality control (QC) techniques to prevent contamination throughout the production line. Image courtesy of Olympus

Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and shake public confidence in the industry.

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers), AWS (American Welding Society) and local regulatory authorities such as the U.S. Food and Drug Administration.

Get the full story from our sister site, Pharmaceutical Processing World.

Using RVI to prevent contamination and maintain purity of pharmaceuticals

Image courtesy of Olympus.

Strict purity and contamination control of pharmaceutical manufacturing facilities is required under various international standards, such as ASME (American Society of Mechanical Engineers), AWS (American Welding Society) and local regulatory authorities such as the U.S. Food and Drug Administration.

Bacterial or foreign-particle contamination in production-line equipment can cause serious health issues for consumers and shake public confidence in the industry.

Preventing contamination in medication production lines is one of the main goals of good manufacturing practices (GMP). Following GMP is a prerequisite for the pharmaceutical industry to prevent poor quality or incorrect mixtures of elements from reaching the consumer. GMP requirements include implementing strict equipment maintenance and cleaning protocols supported by QC and QA inspections and audits, all backed by …

Answering the CDMO shortage: A new paradigm for drug development

Photo by Isaac Quesada on Unsplash

What can the pharma industry do about the critical shortage of contract manufacturing organization (CMO) and contract development and manufacturing company (CDMO) facilities?

For a growing number of young entrepreneurial drug companies, the answer is a middle ground between building their own facilities and outsourcing to the saturated CMO/CDMO market. This middle ground lies in hybrid flexible cleanroom facilities with wraparound support services, which are gaining greater acceptance in the pharma industry. This model allows companies to leverage their manufacturing expertise while still maintaining control of their intellectual property. This approach is particularly valuable as new therapeutic technologies emerge, which require a different competency than many of the existing CMO/CDMO facilities can handle. Hybrid flexible cleanroom facilities are likely to emerge as a n…