Air Quality Concerns for Pharmaceutical Compounding Applications

Pharmaceutical Compounding Defined

Medical drug use in the United States has reached record levels, reaching 6.3 billion prescriptions – that’s roughly 19 doctor-prescribed medications for every US resident (1). Of this number, approximately 1 to 3 percent are for compounded drugs (2), according to the National Library of Medicine.

With so many patients’ lives at stake, it is more important than ever to make sure that the indoor environment in which compounding takes place is clean and free of any contaminants. Failure to do so can not only put medical patients at risk, but the workers who prepare the prescriptions as well.

Pharmaceutical compounding, aka: laboratory compounding, is the process of creating customized medications to meet the individual health requirements of a patient.  Generally done in laboratories, pharmacies, hospitals, or doctor’s offices, drug compounding can be tailored to an individual by adjusting dosages, altering the chemical character of a cream or liquid, substituting ingredients, etc., based on the specifications of the patient’s healthcare professional.

Pharmaceutical Compounding Functions

According to the FDA, compounded drugs should only be used if a patient’s medical needs cannot be met by an FDA-approved medicine. The reason why a patient may need their prescription compounded is variable.  

Examples of situations when compounding is necessary:

1. If a patient cannot swallow pills and needs them in liquid form
2. If a patient has an allergy to a certain ingredient, another can be substituted
3. If a patient has a sensitivity to a certain dye and needs a drug free of colorants
4. If a patient cannot tolerate the taste of an existing drug, special flavoring may be added
5. If a patient needs a specific medicine that is on the FDA’s drug shortages list

Methodology

Typically, the process of compounding medicines involves three steps: formulation, preparation, and quality control.

Formulation – After a doctor determines the patient’s needs, the pharmacist will tailor the ingredients and dosage to that requirement

Preparation – The compounder will precisely measure and prepare the medication

Quality Control – The finished product will undergo strenuous quality control measures to ensure safety and accuracy

During the preparation part of the compounding process, it is paramount that the room in which the compounding takes place is sterile and free of any contaminants. If there are any impurities, the safety of the worker and the integrity of the product are compromised.

Air Quality Concerns

What happens if the IAQ in a compounding facility is anything but clean and pure? Answer: the health and wellness of both workers and patients become jeopardized (3).

Occupational risk for the compounding worker: particulate matter such as pharmaceutical dust can enter a person’s respiratory tract. VOCs and other chemical fumes – such as inorganic gases like CO2 (carbon dioxide) – can be inhaled. All these pollutants can make workers sick.

Patient health risk: if ingredients are contaminated, product safety will become compromised, thus endangering patients.

Air Quality Solutions

Maintaining a clean IAQ begins with workplace administrative controls such as practices and policies that aim to prevent compounding workers from being harmed by hazardous emissions. In addition to this, facilities that perform medical compounding should install and maintain engineering controls such as air cleaning and HEPA filtration, even if they already perform their compounding within the confines of a laboratory clean room.

Understanding the role indoor air pollution plays in safeguarding the drug-compounding industry and its manufactured products is critical to the well-being of patients and workers alike.  At AIRSInc., we have a wide range of air cleaning products, from our fume collection hoods to our HEPA filter media to our dust collection equipment, all designed to capture even the smallest particles at their source.

We have the experience, depth of knowledge, and superior products to protect our customers, their workers, and their products. Contact us today to schedule an appointment with one of our indoor environmental specialists.