Sterile Compounding Injections: Things You Need to Know

sterile compounding

In pharmacy and compounding, sterile compounded medications and their non-sterile counterparts are pretty much standard-issue. When you avail of compounding services, you essentially choose between either of these two categories.

So what makes sterile medicines different? If you’re thinking of having one compounded for you, it’s best to get to know these medications more. This way, you would be able to know the inherent risks involved, their unique benefits, the process of how they’re made, among others.

What Are Sterile Compounding Medications?

Simply put, these are compounded medications that are processed and produced with strict attention to making the products free from any kind of contaminant that can cause infection, may it be a bacteria, virus, or any other applicable pathogen.

That being said, expect these medications to undergo more rigorous testing than other types of medications (i.e. non-sterile medications like gels, creams, capsules, suppositories, tablets, etc.) Pharmacies that do compounding often need to invest in more equipment and tools to ensure proper production, training, testing, and maintenance of these drugs.

This is precisely why sterile options are often always connoted as injections as well. Injectable medications tend to pose a higher risk of infection, after all. In fact, no less than serious diseases like hepatitis and AIDS or HIV can be traced to contaminated injections.

  • Compounded sterile injections can be applied in the standard way (i.e. intravenously) or subcutaneous and intramuscular, and oftentimes, ophthalmic (meaning it’s directly applied into the eyes). We can also argue that various irrigating and inhalation solutions also fall under this category.
  • Of course, each pharmacy has a different way of producing these compounded medications. A Compounding Pharmacy in Florida may have a slightly different approach to sterilization methods compared to other states because of regulations in the said state as well.

Take note that all compounding pharmacies are also required to adhere to the compounding standards set by the USP (United States Pharmacopeia) when creating their sterile injections. 

What Institutions Are Allowed to Prepare Compounding Sterile Medications?

Besides specialized pharmacies like compounding pharmacies, you can also expect them to be available in hospitals, treatment clinics, physicians’ practice institutions, and other applicable healthcare facilities. They’re not limited to pharmacists as well since many physicians and nurses may practice compounding, too, assuming they have the required license. All need to adhere to the USP regulations

What Are the Requirements for Sterilizing Compounded Medications?

Before any institution or company can prepare and create sterile medications, they need to have a certified sterilized room in which to properly produce the medications.

  • This room’s overall air environment needs to be tested and certified to be suitable for sterilizing medications. 
  • It should have sturdy, clean floors, walls, and ceilings at all times. Proper ventilation needs to be installed as well.
  • Sterilizing tools should always be available and easily accessible. These include the availability of gowns, gloves, and ways to thoroughly wash and clean one’s hands.
  • A specialized HVAC with suitable HEPA filters should be installed to control the room’s air pressure when sterilizing.

Expect these requirements to varying a bit in other states or countries. However, what’s certain is that they are often strict. Non-compliance to these guidelines would often result in the license of the pharmacy to create sterile compounded injections to be withdrawn. 

Incidentally, these same requirements are usually not necessary if the pharmacy only produces non-sterile compounded drugs. This should give you an inkling about how seriously governing bodies take the preparation of personalized sterile drugs.

How Do Most Compounding Pharmacies Ensure the Quality and Safety of Their Preparations?

It’s not just about having their products be tested by a third-party lab for many pharmacies. Rather, a few really go to the limit to have their literature peer-reviewed. Others even invest in their own research teams that conduct studies about the integrity of their unique preparations.

  • There’s no shortage of institutions that adhere to a strict quality-assurance methodology. This encompasses regular testing and vigilant inspection of their products in order to ensure that they meet industry standards and even prevent potentially deadly contaminations. 
  • Most also spare no expenses in updating their policies to make sure that risks will be mitigated as long as possible. 
  • Many provide continuous training to their staff and professional pharmacists.
  • Proper maintenance of sterilizing facilities and equipment is also practiced to protect not only patients but employees as well. 

Are Sterile Injections Always Guaranteed to Be Safer than Non-Sterile Medications?

Not really. Just because they’re “sterile” doesn’t mean that there’s already a 0% chance of infection. After all, the entire production process may have ensured this. However, there’s often no surefire way of making sure that these preparations don’t end up being contaminated after they’ve been created.

The consequences of such occurrences can be extremely serious for both the company that prepared it and the patient. It can lead to a major injury or even death, after all. This is why maintaining safe and high-quality sterile preparations is considered an ongoing challenge for many compounding pharmacies worldwide.

  • Incidentally, there’s also the challenge of producing a sterile final product from possibly non-sterile ingredients. Without a doubt, many pharmacies out there will agree that this is one of the most difficult hurdles they often need to overcome.
  • You also have to take note that, more often than not, quality assurance guidelines are often directly proportional to the contamination risk of producing a sterile compounding medication. Almost always, these are the types of compounded products that require extra investments in facilities and equipment that boost safety and risk mitigation.

Bay Life Compounding Pharmacy:

What’s apparent from the facts laid out above is that compounding sterile injections require close compliance with the present good manufacturing practices of states and countries. What’s certain is that it’s one of compounding medicine’s more sensitive sub-branches. 

Considering the high risk involved in the activity, it’s safe to say that compounding pharmacies that manage to maintain a reputation of safety and efficacy when it comes to these drugs deserve all the recognition they get.