Biotechnology/Pharmaceutical Market

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

THE LATEST from Kinetics…

KNOW TO FLOW: Process engineering from Kinetics

Turn fresh insight into wise process engineering plans

Few endeavors carry such weighty consequences as those focused on human and animal health. Whether to test, prevent, treat, or cure, the outcomes of pharmaceutical and biotechnology production are not only important; they are attached to elevated safety standards along with critical environmental considerations.

Kinetics, with close ties to the industry globally, takes the mantel of responsibility seriously in facility planning, construction, and continuing operations. As a result, five important questions are essential for adding rigor when responding to any request for assistance on piping and process modules. Each has a reason, and none stand alone.

DIG DEEPER QUESTION #1: What are the metrics that comprise the project’s ‘dashboard?’

Merely assuming everyone internally and externally has eyes on the same prize is not only inefficient, it can create conflict in the present — along with operational gaps in the future. Based upon past experience, some companies are, for example, exceedingly focused on purity as verified by inline and offline testing. Others, with wider specification ranges, are attuned to efficiency.

DIG DEEPER QUESTION #2: What stages and steps represent the highest potential for variability?

As the data show, there’s significant divergence in process-step sensitivity to changes in chemistry, process environment, and control (whether guided by manual or automatic systems). Kinetics knows that identifying the variable sub-processes puts the spotlight where it needs to be — With specificity and accountability.

DIG DEEPER QUESTION #3: Where are mid- to long-term changes in process or product anticipated?

Continuing research advances may, in fact, mandate alterations in process design, flow, testing, and plant procedures. Striking the balance between high-volume manufacturing of current products and the agility to accommodate future versions calls for early-stage discussions. For example, modules can be installed expressly with the flexibility to make the most of probable changes.

DIG DEEPER QUESTION #4: Is there a need to harmonize a new or upgraded site with others in the production network?

A desire for commonality in process is important to some organizations. Others center exclusively on location- and product-specific requirements. With Kinetics’ full complement of pipe systems and production modules, it is simpler to install more standardized components from within the company’s product line. One outcome can be improved flow of products across the company’s facilities, management fluency with specific technology, and flexibility to shift team members more easily across the network.

DIG DEEPER QUESTION #5: How can the company’s training and development culture be described?

As Kinetics has grown to over 75 supplied installations internationally, the variances in company culture, practices, and local regulations has become more apparent. While the safety of people, products, and environment remain central, an understanding of the plant technicians’ acumen and receptivity is critical. How a facility runs, supervisory staff is deployed, and technology is used to maintain standards across lines and shifts is also important.

Building productive plants rarely happens as a matter of coincidence. As such, starting with insightful questions — and candid responses — can materially affect the outcomes of individual locations; in addition to the entire enterprise. The most effective way to get higher performance in a safety-first setting? Simply click HERE to connect with the Kinetics team.