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The Top Requirements You Need To Know for Your Compounding Pharmacy Cleanroom

Jun 10, 2022 8:43:00 AM / by The Pegasus Team

If you want to run a successful compounding pharmacy, you might be thinking about setting up a compounding pharmacy cleanroom. If you want to put this cleanroom in the best position possible to be successful, you need to stay updated on compounding pharmacy cleanroom standards. There are lots of ISO standards that dictate your cleanroom classification, and you need to be familiar with the different cleanroom classification factors below.

Take a look at some of the most important points regarding your compounding pharmacy cleanroom and do not hesitate to reach out to a professional who can assist you.

What standards should compounding pharmacy cleanrooms follow?

If you are developing a compounding pharmacy cleanroom, the most important standard you follow is called USP 797. This is a far-reaching regulatory requirement that applies to physician practices, hospitals, and pharmacies in which sterile medications and drugs are prepared and stored. Clearly, this applies to a compounding pharmacy cleanroom as well.

Some of the most important standards that pharmacies need to know about this regulation include:

  • The cleanroom has to have an ante area that acts as a buffer area before someone enters the cleanroom itself.
  • The room has to meet ISO Class 8 standards.
  • The positive pressure has to be compliant with ISO 14644-4.
  • The room has to have a handful of physical characteristics related to construction. A few examples include smooth walls, floors, ceilings, and fixtures. There cannot be any cracks or crevices in the room. The surfaces should not have any damage from sanitizing agents.
  • Before entering the cleanroom, everyone has to remove their lab coats, jewelry, and makeup, and follow all scrubbing procedures. All personnel needs to wear gloves, gowns, masks, hair covers, and shoe covers before entering the room.

These are just a few of the most important requirements that a compounding pharmacy cleanroom has to meet. It is also important for every compounding pharmacy cleanroom to have a formal audit program, in writing, that covers all of the relevant requirements discussed above.

Cleanroom Cleaning Process Guide

What can you do to keep your compounding pharmacy cleanrooms up to standard?

There are a few ways that you can keep your compounding pharmacy cleanroom up to standard. One of the ways to do so is to institute the formal audit program mentioned above. Some of the components of the program should include:

  • The program has to cover all aspects of both preparing and dispensing medications.
  • The audit program needs to have objective measures that clarify how the cleanroom is going to be judged.
  • The program needs to have clear measures in place for how to rectify situations if certain aspects of the compounding pharmacy cleanroom are not up to standard.

With everything you have to do during the day, you may have a difficult time keeping up with the audit program. That is why it is a good idea to outsource your cleaning services to a professional team that can help you make sure that your compounding pharmacy cleanroom is up to the latest standards.

What cleaning should you do, and when should you partner with a professional cleanroom cleaning service?

If you want to keep your compounding pharmacy cleanroom clean, there are specific cleaning services that you need to do. A few examples include:

  • You need to make sure that you mop all of the floors using a damp mop with the right cleaning solutions. Then, you should use a vacuum to dry the floor.
  • You should also make sure that you vacuum the walls. It is a good idea to use a HEPA filter vacuum to make sure you clean everything.
  • You need to wash and wipe down every pass-through area. You last make sure you dry them as well.
  • Between shifts, make sure you put away all products to avoid further contamination.

This can be a bit of a hassle, so it is a good idea to partner with a professional cleaning service that can help you keep your compounding pharmacy cleanroom clean. If you find that your overhead expenses are increasing, that you are having a difficult time maintaining these high standards of cleanliness, or if you are concerned about potential government fines and sanctions, it is time to reach out to a professional cleaning service.

What is the benefit of using a professional cleanroom cleaning service?

There are several significant benefits of using a professional compounding pharmacy cleanroom cleaning service. They include:

  • You get to work with a professional team that understands what standards need to be met.
  • You can save time because you do not need to worry about hiring, recruiting, or training your own cleaning service.
  • You can save money because you don't need to worry about paying for your equipment or cleaning solutions.
  • You can reduce your regulatory liability by partnering with a professional team.

For all of these reasons, consider outsourcing your compounding pharmacy cleanroom to a professional service.

Contact Pegasus for Professional Commercial Cleaning Services and Download Our Guide Today

It is important to keep up with the different ISO Classification standards for a compounding pharmacy cleanroom, and you need to work with a professional team that can help you with Cleanroom Cleaning. At Pegasus, we have a tremendous amount of experience working with a wide variety of clients, and we can help you if you are developing a compounding pharmacy cleanroom and you want to keep it clean. Give us a call today to speak to our team to learn more about our cleaning services and get your instant quote. 

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