Pharmacy Compounding Labs
CAP Temperature Monitoring System Guidelines
June 21, 2021
Aerospace Condition Monitoring
August 10, 2022Most of us are quite content to pick up our prescriptions or over-the-counter medications without a second thought as to where they come from. But what about those prescriptions that are not working?
Sometimes, our prescriptions are not working as well as they should, or we have a certain reaction to them. That means the standard of that medication needs adjustments. No one should be treated with the same medication each time. While dosages vary, the symptoms and the patients still require much more for their medications.
Taking the same medication for months and months without any results is a waste of money and can have adverse effects on the patient. That’s why there is an increase in pharmacy compounding. People need more.
What Are Compounding Pharmacies
There was a time when all medications were prepared to spec when they were ordered. Small pharmacies in your neighborhood had all the preparations they needed to put together your prescription. But, as the population started to grow, it became the norm for pharmacies to mass-produce even more popular medications and keep them in storage. This saved time and money rather than making up each prescription from scratch.
But this isn’t an ideal situation for the patient, just the pharmacy. No person or their symptoms are the same, yet they are expected to take the same medications.
Recently, there has been more and more demand for compounding medications. This is due to people having reactions to standard medications, or not being treated properly. It’s quite simple. The same pill simply doesn’t do the same for every patient. Whether it is ourselves or a loved one, there is no reason why every patient shouldn’t have the exact medication they require.
What Do Compounding Pharmacies Do?
If your standard medications are not working, or you are having an adverse or allergic reaction, then the medications need to be either adjusted or made to suit. Allergies, reactions, or no reaction at all are changing the way people are getting their prescriptions. The compounding pharmacy can make medications from scratch, adjust the levels of medication, and even add or take out certain ingredients. They can make the medication safer or lower the active ingredients if it is for a child.
They can also take a standard medication and make it into a different form, so it is easier for the patient to take it. They can make it into a smaller form or a liquid form. These can also be made into creams, topical, edibles, powders, ointments, or other forms. This not only helps the patient to take the medication more easily, but it can help prevent certain side effects that have caused problems in the past.
These can be made into a substance that can be hidden in food or made to resemble foods. This is ideal for children, pets, or a senior with dementia who won’t take medications.
Dyes, hormones, or other ingredients that a person may be allergic to can be removed or replaced with something else. Compounding can also involve adding colors or flavor's to medications, to make them easier for children. As more pharmacies offer compound medications, the regulations for this have also increased. There are very strict guidelines for compounding pharmacies that require a lot of specialized training, education, and equipment.
Compounding Labs
Compounding pharmacy labs need to meet certain standards. They need to meet standards when it comes to the facility itself and has other standards, depending on what is being prepared.
There is often a need for several separate preparation rooms, where certain ingredients can’t mix or contaminate. Sterile or non-sterile, hazardous, or non-hazardous, and the state laws regarding these ingredients mixing, if at all. The setup for these labs often requires a workroom and an anteroom. There is often a sterilized passageway, as well. This is to avoid any cross-contamination of any of these active ingredients.
There is a cleanroom where the work is most often completed. There will be workstations in this room, but it needs to be away from all the other areas. The air quality in these rooms must be maintained. The workrooms must be isolated from all other areas, like the pharmacy, storage, passages, and anteroom. There also needs to be windows, for observation and mental health.
Pressure Differential
Possibly the most important concern with these rooms is the pressure. The pressure needs to be positive pressure when working in the cleanroom unless working with hazardous ingredients.
Positive pressure allows the airflow out of the room instead of in. This means that the air in the cleanroom will tend to leak out of the room, instead of in, which prevents unfiltered air or air particulates from getting in. However, in a hazardous compounding area, the pressure is negative to prevent air that might be contaminated by hazardous products from escaping the room. Therefore, the negative pressure pushes the air towards the clean zone.
Monitoring Pressure
Because the pressure of the room is vital, it needs to be monitored. If the air pressure is off, it can ruin the entire batch of medication being produced. This means that the rooms all need to be monitored at the same time. Not just pressure, but temperature, humidity, and other aspects all need to be monitored constantly. Technology allows this to happen with the TempGenius Wireless Pressure Sensors.
Placed inside the equipment, it can monitor, report and alert you to any changes that are happening that can alter the results. This constant monitoring and data gathering saves time and money.
TempGenius can determine any equipment that may be faulty or in need of repair or replacement. It also keeps monitoring even when there is no one around. All the data it gathers is stored and backed up in case of power failure. It keeps track of all your pre-set functions and alerts you when these vary or change, even a little bit.
You can also access this information remotely. If you are out of range, the system will send out an alert to the indicated contact via email, phone, or text message. The alert feature works independently from your computer and allows delivery schedules based on recipient, any time or day. It decreases the downtime for you and the labs by sending alerts about faulty equipment.
Pharmacy Compounding Labs
Not only are the ingredients a vital part of the compounding but so are the conditions. The pressure and the cleanliness of the room must be perfected to make the prescription as best as it can be. The slightest variation can make the entire process void and ruined. This costs pharmacies a lot of time and money. Using the best equipment under the best and ideal conditions will ensure every batch is perfect.
What Sets TempGenius apart from other Monitoring Systems
A Proven Track Record and Vast Experience
You do not need any random provider for your monitoring; you need a company that works solely on temperature monitoring solutions. It also needs to have a variety of customers and unmatched knowledge. TempGenius has been working on temperature measurement and recording solutions for many years. We take pride in our plethora of partnerships with renowned medical and healthcare entities in the US.
Compliance with the Set Standards
TempGenius temperature monitoring systems are designed and developed to the highest standards. They have met requirements from the CDC, FDA, CAP, ISO 17025, CLIA, Joint Commission (JC), HACCP, and USDA. Furthermore, we provide enterprise temperature alarms and complete temperature logs when Critical Compliance (CCP’s) are out of compliance.
We Provide Certified Calibration Services
With a vast array of software apps and products, we deliver top-notch calibration services that can support validation, traceability, compliance, and quality assurance. Our systems will help you record and monitor deviations and inaccuracies in detail and provide precise results.
Durable and Reliable Systems
Our temperature monitoring platforms are a culmination of robust expertise, cutting-edge technology, and unparalleled experience. Our ultra-stable platforms are created to give you the best performance and durability.
Contact us to customize a Temperature Monitoring Solution for your enterprise.
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