Respiratory Protection during Hormone Pellet Compounding

For years, men and women have turned to hormone pellet therapy for assistance in regulating their body’s hormone levels.

Pellets differ from other forms of hormone therapy, like injections and oral capsules, in that they are implanted underneath the skin for a slow, steady absorption rate rather than an entire dosage all at once.

Larger than a grain of rice but smaller than a Tic-Tac®, these pellets require only a small incision and can last up to 4-6 months.

Investigational Therapy

While many adults experience positive results from pellets, studies have found that their effects are unpredictable and fluctuating.

As a result, the FDA and Maternal Health Drugs Advisory Committee unanimously agreed to terminate compassionate investigative new drug programs for estrogen pellets as a last-resort treatment of menopausal disorder.

Because subcutaneous hormone pellet implantation is considered investigational, there are currently no FDA-approved, commercially available formulations in the United States.

So how does this affect users of hormone pellets? They turn to compounding pharmacists.

Unintentional Hormone Exposure

Depending on the end user, hormone pellets are comprised of either estradiol or testosterone. In some cases these hormones are mixed together into a pellet.

Compounding pharmacists will commonly use a form a trituration to mix the various powdered ingredients together.

Trituration is simply a name for several different methods used to process materials. Process methods can include grinding one compound into another, reducing the particle size of a substance, or producing a homogenous material by mixing component materials thoroughly.

As with any process that grinds powders into a fine state, plumes and dust generate. For compounding pharmacists, these powder plumes pose a health hazard if inhaled.

Imagine the long-term side effects on a male pharmacist who compounds estrogen pellets in his practice. Imagine the same effects on a healthy female pharmacist who compounds testosterone pellets in her practice.

Over time, inhalation of these plumes could have an effect on their own hormone levels. Because of this, it is important for compounding pharmacists to work within a well ventilated enclosure.

PARR Pellet Press System

Pressing Pellets

Once the powdered mix is ready, a small measured dosage is poured into a hand press machine where the powder is compressed into its final pellet form.

In the series of images to the right, a popular commercially-available hand pellet press is being demonstrated.

Between each batch of pellets, the pharmacist may use compressed air to clean the press machine of any residual powders as not to contaminate a new batch.

The process of cleaning the machine with compressed air will also create a small plume of fine hormone powder dust which should not be inhaled. Again, this process should be done within a well ventilated enclosure to protect the pharmacist’s breathing zone.

Powder Containment Hoods

A “well ventilated enclosure” should, at minimum, be comprised of:

  • HEPA Filtration (up to 99.97% efficient on particles 0.3 microns in size or 300 nanometers)
  • Adjustable Airflow
  • Adequately-sized Work Area

A quality HEPA filter has been shown to trap pharmaceutical powders within its paper media and is an industry standard for filtered enclosures.

Regulation of airflow within the enclosure is key to handling powders safely. Too little airflow has minimal to no effect on pulling the dust plumes into the filter media. Too much airflow can cause turbulence within the enclosure and have a negative effect on dosage measurement and powder handling.

An appropriately-sized hood makes working within the enclosure more comfortable and allows the placement of equipment and materials to match the pharmacist’s work style.

Sentry Air Enclosures

Sentry Air Systems has a line of Pharmaceutical Powder Containment Hoods for non-sterile compounding. These ductless enclosures allow pharmacists to safely weigh, measure, and compound prescription dosages.

A powerful fan and filtration system pulls the airborne powder and particulate away from the operator and directly into a HEPA filter. These hoods do not require ductwork or exterior ventilation, making them easy to move around a pharmacy or lab.

A variable speed control knob comes standard and allows for manual air volume adjustment. An optional magnehelic gauge is available to assist in monitoring the HEPA filter’s saturation level.

sas powder containment hoods

Video

On our YouTube channel we have a video demonstrating one of our Ductless Containment Hoods for a pharmaceutical capsule filling process.

Previous Blogs

Disclaimer

Our line of pharmaceutical powder containment hoods are not intended for sterile compounding applications.

Contact Sentry Air

If your non-sterile compounding practice could benefit from powder containment, give Sentry Air Systems a call. One of our technical applications specialists will work with you to determine the best solution. Call 800.799.4609, email sales@sentryair.com or fill out the comment form below.