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USP Compliancy: What’s Holding “YOU” Back?

It is reported that roughly 63% of U.S. hospitals do not meet or exceed requirements with regards to USP 797; even though the date for compliancy is about 90 days away.1

Non Compliant nametag

What's holding you back?

We see many hospitals still on the fence and confused, which has caused procrastination about which way to go. Common reasons behind this are:

  • Money/financing
  • Too difficult to deal with now
  • Not knowing if they have enough space
  • Not sure if they are already compliant

Honest conversation about compliancy

It's easy to see how many may see becoming compliant as a stressful situation with so many questions, so we have developed a specialized team to answer all inquires you may have about compliancy including why choosing a modular cleanroom will save you money and headaches in the long run.

Why is that?

At first glance, having a permanent, stick built cleanroom may seem ideal to heads of pharmacy and hospital CFOs, because they are cheaper to initially manufacture, but after further analysis, many times, they end up costing hospitals more headaches; having to dig deeper into their pockets than they initially thought or can afford.

Within the industry, we see a trend in major regulations being implemented every 5–10 years. In order to comply with many of these regulations, remodeling, redesigns, or relocations of your existing cleanroom need to be considered. Those who do not look ten years into the future may realize what saved them money initially has cost them so much more in the “not so distant” future.

Here are the two, most common scenarios we see within becoming compliant.

Scenario one: Existing, stick built cleanroom

Like an old car, a cleanroom goes through inspections, and may give “decent” readings, but the inevitable cannot be avoided. Sooner or later, it will be obsolete; requiring major modifications, from electrical and water supplies, HVAC, plenum size and placement, air flows (velocity and direction) and exhaust, wall placement, etc.

Just like an old car, a decision must be made to continue to dash out more and more money, or to make a new investment into a new cleanroom; or new, additional cleanrooms.

The main difference between a modular and a stick built cleanroom comes down to the adaptability/flexibility, including several parameters, such as:

  • Location: Using a modular cleanroom enables you to remodel any existing space into a compliant cleanroom.
  • Scalability: The size of a modular cleanroom can be changed over time in accordance to your operations and needs. Build what you need today; grow when you need, tomorrow.

Scenario two: The need for additional cleanrooms

There are several reasons why a hospital may need additional cleanrooms:

  • Expansion of hospital: As our population and lifespans grow, hospitals may need to grow as well.
  • Pharmaceutical manufacturing: More patients in need of compounded medicine/ more cost efficient than outsourcing.
  • A Matter of Logistics: Having smaller cleanrooms on different floors saves time, as well as money in the long run. It also guarantees there are no drug shortages from external suppliers.
  • Non-compliant: Existing older cleanrooms are expected follow the general standards of USP Chapter <797> and <800>, while reevaluating if the cost to remodel justifies the continued investments.
  • Outsourcing not always ideal: Certain drugs have a lifespan of a few hours. Delayed delivery caused by traffic or other interruptions can cost hospitals tens, upon tens of thousands of dollars. Internal compounding, especially in cases where the patients' cells are the drug, re-infused intravenously, time is of the essence.

Summary

We can't predict the future, but we're certain compliance is in it.

Expert advise

To read more about turn-key cleanroom solutions, click here and find out why QleanSpace is “more than just modular”.

Have more questions about compliancy, design, logistics, or budget? Just reach out to us!

QleanAir Scandinavia offers hospitals and health care providers advice and solutions in helping future-proof your operations through every phase of cleanroom development.

1 Source: State of Pharmacy Compounding, April 2018

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