There is an anteroom in a pharmacy.

If you don't know how to build a sterile compounding pharmacy, you can trust Mecart to help.Pharmacy regulatory inspectors recommend Mecart cleanrooms.We guarantee that your sterile compounding cleanroom will be compliant with the requirements.We know how challenging a project like this can be because we have been involved with several pharmacists who were looking for sterile compounding cleanrooms.

Here are some insights about the design of a sterile compounding pharmacy.

Which standards and regulations must you follow?When our clients call for a quote, we ask them this first question.There are three main aspects that determine which regulations apply to your compounding facility: the type of preparations that will be compounded, the geographic market in which you will operate, and Canada.

It is possible to compound both hazardous and non-hazardous preparations in two clean rooms sharing the same anteroom and support zone, but strict conditions must be respected.For more information, read the applicable norms.

The areas reserved for compounding should have at least two separate areas: a clean room and anteroom.There is a third room called the support room, but it is not necessarily enclosed or classified.

There are workstations in the clean room or buffer zone.The primary engineering control is installed here.The clean room must be isolated from the rest of the pharmacy and unclassified areas to reduce the risk of introducing contaminants.Walls, pass-throughs and doors separate the areas.ISO Class 7 air quality must be maintained.One or more observation windows must be installed to allow the pharmacist to observe activities being conducted inside.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 moreImagine being trapped in a room with no windows for a long time.

The anteroom is a closed passage between the clean room and the support zone in which technicians perform support tasks.It has two doors with a closing system that only opens one door at a time.There is a transitional space between the clean room and the unclassified support zone.The anteroom is usually equipped with a sink, cabinets and a bench, but activities in this area must be kept to a minimum.Depending on the risk level of the sterile products being prepared in the critical area, the anteroom can be engineered as an ISO 7 or ISO 8 environment.The clean room must be entered through the anteroom.

Every regulation doesn't mention the support zone.The unclassified zone is used for material storage, validation, entry of prescriptions, and other things.

An unpacking and storing zone in a properly ventilated room with air being exhausted to the exterior may be required for hazardous product compounding.

The sterile compounding facility has mechanical, electrical and plumbing requirements.The mechanical aspects focus on heating, cooling and ventilation, the electrical aspects provide power to all outlets and appliances, and the plumbing aspects deliver water and drain waste water.Cleanrooms usually have their own electrical panel.Ensuring that the building can provide electrical power is important.The anteroom requires drainage and water supply.

When dealing with hazardous preparations, cleanrooms must be held in negative pressure.The pressure differential is the most important thing between the three zones.The anteroom needs to have a greater pressure gradient than the support zone.The air will flow out of the room if there is positive pressure.The air in the clean room will leak out, instead of in, thus preventing air or air particulates from entering.In a hazardous compounding facility, the pressure is negative in order to prevent the air in the room from being contaminated by hazardous products.The air is pushed towards the clean zone by the negative pressure.

It is different from conventional ones.In order to choose and engineer the appropriate system and maintain the required parameters, the HVAC system must be specified by the specialists.

The supply of clean air to the cleanroom is controlled by the heating, ventilating, and air conditioning system.The air comes from the ceiling.The contaminated air is pushed to the exits through the return air intakes at the bottom of the walls.The comfort of employees is dependent on the air conditioning system.Depending on the size of the room and the number of people working inside, the air changes per hour may have to be greater in the clean room.

The information, statements, opinions and analyses provided in this document are intended to provide helpful and educational information on the subjects discussed.The opinions and views of the authors are subject to change without notice.Every effort has been made to ensure the accuracy of the information in this document.No representations or warranties are made as to the accuracy, validity, correctness, currentness, completeness, or suitability of the information.The statements provided are not meant to be used for any specific application or project without further analysis, evaluation, verification and assessment.Any error, damage, loss, injury or other consequence which may arise from use in any manner of any information contained in this document will be declined by MECART.Before entering into a project, it is advisable to seek the advice of a competent professional.