Stay in the Lead with Your cGMP Process


Friday, July 01, 2016

What may have been high-end equipment 20 years ago may cause your company serious problems now. While it may function reliably, if your drug manufacturing process isn't cGMP compliant, you risk regulatory action from the FDA. Ensure your system meets FDA standards now, by contacting a White Mountain Process specialist to review your current mixing system.

Current Good Manufacturing Practices (cGMP) are necessary guidelines for drug manufacturing. While people assume all manufacturers adhere to these practices, remarkably some manufacturers have not upgraded equipment to current processes and standards.

When it comes to drug products, cGMPs provide a solid foundation for good product quality. Our trained specialists can help you determine current weaknesses in your production and mixing equipment so you can remedy any potential problems quickly. We offer design assistance, necessary documentation, and can help you create a cGMP compliant manufacturing process in your lab to certify product purity.

With the proper systems in place, your manufacturing can guarantee product quality, thanks to strict quality management systems and solid operating procedures. We can help you take your drug manufacturing to the next level by assisting you with critical upgrades in equipment and record keeping strategies. Your company will enjoy the two-fold benefits of smarter production processes - including greater efficiency and a better end product.

Are contamination issues, product mix-ups, waste and errors a problem for your drug mixing production? Be sure your products meet quality standards with the latest in high performance equipment. Introduce the latest mixtank equipment designed for CIP and SIP processes, mixing designed for portability and improve your overall mixing processes and results.

Is your goal to apply more internal stringent requirements?

If quality is your company's number one goal, let us introduce you to modernized systems which will greatly exceed minimum FDA standards. We build quality into your mixtank, taking into account your specific mixing procedures so you can develop reproducible processes and measurable results to guarantee the safety and effectiveness of the products you manufacture.

Have the assurance that your systems will pass critical inspections by following cGMP standards and regulations with robust mixing systems from White Mountain Process. Contact us to help with:

  • Solid to liquid applications requiring aggressive mixing
  • Efficient mixing for a wide variety of applications
  • Single-use mixing systems, single-use mixing bags
  • Buffer and media prep
  • Design assistance for setting up your cGMP certified cleanroom
  • CIP and SIP mixtank systems
  • Individual accessories, or complete, turn-key mixtank solutions
  • High shear mixers and granulators
  • Bulk containers, wash stations and blenders

Since the pharmacological and pathophysiological implications for cGMP drug production are many, White Mountain Process stays abreast of all changes and modifications, as well as the demands in the industry by major players in the drug manufacturing industry. Put our experience to work for you with engineering assistance, processing tips and valuable advice from the professionals who deal with high-end mixing every day.

With properly designed mixing systems tailored to your process and application, your products can make a difference in the life of your end customer, as well as your bottom line. The professionals at White Mountain Process can help you improve your mixing processes, from start to finish, including reporting and cleaning routines. It's our goal to help your company provide advanced mixing processes and thereby helping you to assure your pharma or biotech mixing department is providing consistent quality to customers, every time.

Call us today to help your company stay ahead of the curve by developing effective and safe batches consistently.

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