FLOWING TO THE CHALLENGE
The pursuit of improved human health isn’t a casual activity. The journey from hypothesis to practical application to regulatory approval is beyond daunting: Few companies have the self-belief, fortitude and resources to complete the journey.
Those committed to extending comfort, accelerating healing, combating disease and stopping pathogens deserve the support of top-tier process partners. Central to selecting these trusted allies is confidence in their ability to perform in the real world.
Process engineering is simply the start, with flow creation to unite stages and steps becoming an enterprise imperative as diagrams are channeled into specifications. Rather than glorified plumbing and pumps, there’s an elevated standard at work. That’s true even with pharmaceutical facility upgrades.
Even smaller-scale research labs must demonstrate diligence, repeatability and safety with every initiative. Data integrity is critical and relies upon precision that protects the lab environment as well as the health of technicians: Safety is the first attribute of each product released.
Kinetics’ experience spans a wide range of operations, from small research laboratories to complex pharmaceutical manufacturing facilities. Kinetics’ competencies including planning, fabrication and installation of process modules for biological processing and pharmaceutical facility upgrades.
With documentation systems in compliance with all cGMP requirements, Kinetics has provided many types of pharmaceutical and biotechnology piping and process modules to over 75 facilities in the United States, Europe and Asia. These extend well beyond pharmaceutical facilities upgrades.
To accomplish this, the Company’s product capabilities address both uncommon and recurring demands:
- Purified water systems (WFI, USP, RO/DI) Pure steam
- Process gases
- Waste water systems
- Fermenters and bio-reactors
- Buffer and media preparation and storage systems
- Clean-in-place (CIP) and sterilize-in-place (SIP) systems
- High purity sanitary process piping installation and passivation
- Wet/dry side HVAC
- Process vacuum systems
- cGMP qualification and validation
- Documentation to cGMP requirements
- Waste-kill systems
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In the pressurized world of human health product development, every stage and step are demanding. From lab bench to end-user shelf, the complexities are manifold as well as daunting, even as cost management turns pure exploration into a responsible, fiscally accountable enterprise for projects including pharmaceutical facility upgrades.
By building and installing process modules throughout the world, Kinetics has discovered some common characteristics among successful installations: Those that produce data, components or finished products that align with expectations, or at points, serve to exceed them.
The TOP FIVE SECRETS of productive installations:
1) REALITY GETS BUILT IN, primarily by accounting for variances in environmental conditions and operator skill. Conversely, even those depending on automation for consistency can be frustrated by something as rudimentary as electrical supply quality.
2) OUTCOMES ARE CLEAR including whether other processes or products are anticipated to flow through the system under development. Can altered material characteristics be accommodated? What will happen to capacity much less quality delivery?
3) SPACE ISN’T SQUEEZED to the point of impaired access during and after installation. Apart from the most adept crews, it is tempting to hurry assembly and testing to flee from a submarine-like space. Being prepared for maintenance isn’t accidental, either.
4) SUCCESS ISN’T A SURPRISE such that back-end packaging, storage and security need to have some upside capacity: Assuming these problems are noble and can be overcome easily is not what wise operators consider at the start, when greater volumes are anticipated.
5) SAFETY REMAINS THE DRUMBEAT and is never assumed. While a production module may function well independently, its interconnection with others may create the potential for a weak link and unintended consequences. Contamination is the relentless enemy from start to finish.
Learn more about Kinetics’ total approach to providing many types of pharmaceutical and biotechnology piping and process modules. Including those aligned with pharmaceutical facility upgrades. And take advantage of a world of best practices accrued in the United States, Europe and Asia. Email firstname.lastname@example.org to connect with one of our experts.