How to become a compounding pharmacist(setting up and operations):
Sometimes a “one-size-fits-all” approach to medication means that patients’ needs are not met by a traditional registered pharmacy. The ability for a pharmacist to compound therapeutical products tailored to suit the needs of their consumers can give the pharmacist a good reportagé.
Owners of registered pharmacies may wish to look into adapting their business and premises to allow for it to provide for compounding pharmacy services. The process of change from a registered pharmacy to a compounding pharmacy is made easy by the fact that there are no additional registration or licensing requirements to be met to enable a pre-registered pharmacy to begin compounding therapeutic products on the proviso that the pharmacy is open to the public.
Why become a compounding pharmacy?
Compounding therapeutic goods permits a pharmacist to adjust the strength of the medication and remove certain ingredients (such as dyes, preservative, lactose, gluten, or sugar) to accommodate for allergies. Enabling a pharmacist to make such alterations to the therapeutic goods sold may expand the consumer base for the medications that a particular pharmacy can provide, and enhances a pharmacist’s ability to offer tailored medication with a higher likelihood of being effective.
What then is a compounding pharmacy/ist?
Basically, a compounding pharmacy—or compound pharmacy—is a pharmacy that makes certain medications from scratch, says Lars Brichta, Pharm.D., director of clinical and scientific affairs for ChemistryRX, a compounding pharmacy in Philadelphia that specializes in medications for skin conditions and rare diseases. However, these pharmacies are anything but basic.
Most pharmacists simply dispense medications that arrive at the pharmacy premade. At compounding pharmacies, the pharmacists actually customize medication for each individual patient and his or her unique needs, as long as that drug is not available from a drug manufacturer. The ingredients are kept on hand, and when a patient needs a particular treatment, a compounding pharmacist mixes it up from these ingredients. For this reason (and others), compound drugs are exempt from FDA-approval, and instead are regulated by state boards of pharmacy based on standards set by the United States Pharmacopeial (USP) Convention. Pills and tablets are not commonly compounded. But, liquids, creams, ointments, lozenges, suppositories, and often capsules are compounded.
Things to consider when starting up a compounding pharmacy..
1. CONSIDERATIONS IN CLEANROOM DESIGN –
If you’ve decided to launch your sterile compounding pharmacy, building a the cleanroom, is one of the major criteria
In hopes of making things clearer to you, here are some insights about cleanroom design for sterile compounding pharmacies.
1) Be aware of the applicable norms, standards and regulations.
2) The typical layout for sterile compounding.
3) Pressure differential.
4) Heating, ventilation and air conditioning system (HVAC).
1) BE AWARE OF THE APPLICABLE NORMS, STANDARDS AND REGULATIONS
Which norms, standards, and regulations must you comply with? This is one of the first questions we ask our clients when they call for a cleanroom quote. Roughly speaking, there are three main aspects that determine which regulations apply to your compounding facility: the type of preparations that will be compounded (sterile or non-sterile, hazardous or non-hazardous); the geographic market in which you will operate, both provincial/state and national (Canada, USA); and also the geographical markets in which your compounded preparations will be sold.
WHAT TYPE OF PRODUCTS WILL BE COMPOUNDED?
-Non-Hazardous Sterile Compounding Preparations
-Hazardous Sterile -Compounding Preparations
Hazardous Non-Sterile -Compounding Preparations
Non-Hazardous Non-Sterile Compounding Preparations.
Although it is not recommended, it is possible to compound both hazardous and non-hazardous preparations in two adjacent clean rooms sharing the same anteroom and support zone, but strict conditions must be respected. Read the applicable norms for more information.
2) THE TYPICAL LAYOUT FOR STERILE COMPOUNDING
typical layout sterile compounding cleanroom
The areas reserved for compounding preparations must have at least two controlled, enclosed and distinct areas: a clean room (or buffer zone) in which the Primary Engineering Control (PEC) is located, and the anteroom. Some regulations strongly suggest a third room known as the support room, but this area is not necessarily enclosed nor is it classified.
▪️Buffer Zone / Clean Room (ISO 7)
The actual clean room or buffer zone/area is equipped with workstations. This is where the primary engineering control (PEC) (such as LAFW, BSC, CAI and CACI) is installed. To reduce the risk of introducing contaminants, the clean room must be isolated from the rest of the pharmacy as well as from unclassified areas. Walls, pass-throughs and doors serve to separate the areas. ISO Class 7 air quality must be maintained under dynamic operating conditions. To allow the pharmacist to observe activities being conducted inside, one or more observation windows must be installed. These windows are meant to reduce the non-essential back-and-forth entries into the control areas, as well as offering safety factors, (to be able to see what is going on inside the cleanroom in case of an emergency) and also for your employees’ comfort, creating a more enjoyable, and thus productive work environment. Imagine being trapped in a room with no windows for hours on end!
▪️Anteroom (ISO 7 or 8)
The anteroom, also called ante-room, ante-area or antechamber, is a closed passage between the clean room and the support zone in which technicians perform support tasks (gowning, hand and forearm hygiene, labelling, etc.). It is equipped with two doors with a closing system that allows to open only one door at a time (interlock). It is actually a transitional space between the unclassified support zone and the clean room. The anteroom is usually equipped with a sink, cabinets and a bench, but equipment and activities in this area must be kept to a minimum. The anteroom can be engineered as an ISO 7 or ISO 8 environment depending on the risk level (HD or non-HD) of the sterile products being prepared in the critical area. Everything that enters the clean room must be taken through the anteroom.
The support zone is not mentioned in every regulation. It is an unclassified zone that may be enclosed or not, and is used for material storage, validation, entry of prescriptions, etc.
▪️Area for unpacking and storing (HD products)
For hazardous product compounding, an unpacking and storing zone in a properly ventilated room with air being exhausted to the exterior may be required.
3) PRESSURE DIFFERENTIAL
Cleanrooms are held in positive pressure, except when dealing with the compounding of hazardous preparations, which must be held in negative pressure. The most important thing between these three zones is the pressure differential. It is crucial that the pressure gradient of the clean zone be greater (at least 5 Pa) than the anteroom’s, and that the anteroom’s pressure gradient be greater (at least 5 Pa) than the support zone’s. Positive pressure will make the air flow out of the room instead of in. What this means is that the air in the clean room will have a tendency to leak out of the room, instead of in, thus preventing unfiltered air or air particulates from entering. That being said, in a hazardous compounding facility, it is the opposite: the pressure is negative in order 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”
4) HEATING, VENTILATION AND AIR CONDITIONING SYSTEM (HVAC)
The HVAC system is the most important part of a cleanroom since it controls the supply of clean air to the cleanroom. The air intake comes from the ceiling, and is filtered through HEPA filters. The new air travels down the room, pushing the contaminated air to exits through return air intakes at the bottom of the walls. The air conditioning system is important for the employees’ comfort since wearing personal protective equipment can be quite hot. The air changes per hour (ACPH) must be of at least 30 in the clean room and of 20 ACPH in the anteroom, but may have to be greater depending on the size of the room, the number of people working inside, etc.