Clean Room For Medication | Proficient Rx

What Makes A Clean Room Important For Prepacking Medication?

If you were to find out the medicines you prescribe were being manufactured in a seedy, cluttered, dirty environment, you would cancel your orders with the manufacturer. You do not want your patients receiving medications that could be contaminated. You want the medicines you prescribe to be created in a controlled environment such as a clean room.

Clean rooms help provide this healthy environment during the manufacturing of pharmaceuticals. Clean rooms focus on the air in the facility where drugs are manufactured. If the air is clean, everything else in the facility will be cleaner.

A clean room is defined as the space used to contain an area that needs to be free of particles that could potentially contaminate a product. They are also used to control temperature and pressure.

Why Use a Clean Room?

Every manufacturer, in any industry, wants to protect their products. If they realize particles can influence their process, they will use a clean room.

Clean rooms can vary in size, depending on equipment and complexity of the process.

For prepacking medication, temperature, humidity and air pressure are all crucial factors and must be heavily monitored. Using a clean room is essential. If you find the prepacking company you work with is not using a clean room, it is time to switch to one who does.

Your patients can be affected by any time of facility contamination, even it is with the smallest particles. Therefore, prepacking companies take extra steps to follow classification guidelines.Clean rooms help companies remain compliant with Good Manufacturing Practices.

Construction of Clean Rooms

Clean room construction follows guidelines that protect the quality of the air in the manufacturing plant. From corridors to which way the doors swing is taken into consideration. Several other factors make a clean room sterile.

Surfaces inside a room such as countertops can make a difference in keeping a room up to standards. How the air flows through the room and even the personnel and what they bring in the room when they enter can be factors also.

Classification of Clean Rooms

Clean rooms are classified by how clean the air is in the facility. There is a maximum number of particles allowed. It would be impossible to remove all particles, so strict limits were set in place. Classification is determined by the source of contaminations, what size particles are needed to filter out and how much air needs to be circulated to get rid of the contamination.

Being place in a class, a company is being confirmed that they meet the standards of that class. For instance, a class 5 clean room is built so that no more than 3,500 particles are in the room.

Clean room classifications range from an ISO 8, this being the maximum level. ISO 4 levels maintain stricter guidelines and mostly apply to the electronics industry. Pharmaceutical manufacturing clean rooms range at levels between 5 and 8, sometimes higher depending on the drugs being packaged.

These numbers tell an inspector the number of particles found in a room. They not only measure the number of particles that enter a room, but also the number of particles that leave the room.

Clean Room Personnel

Staff working in a clean room are heavily controlled. There number of personnel in the room at one time is limited. The more staff, the more potential for contamination.

Personnel must undergo training on clean rooms, environmental safety and what to do in case of accidents or contamination issues.

Personnel are required to wear specific protection clothing while in the lab. They have guidelines to follow when dressing and undressing.

Personnel must know how to operate a clean room effectively. They must know how to keep the room clean with the implementation of steps established to avoid contamination. They must know how to change air filters, clean the room and monitor air flows into the room.

The clothing used by personnel has its own strict guidelines.

Clean Room Clothing

The clothing worn in a clean room is heavily restricted and must meet guidelines that ensure safety for the product and for the personnel.

Garments are made specifically for clean rooms. Depending on the needs of the facility, personnel will wear garments suited for the following: sterile, sterile protective, process only, bio clean, stat guard dust coats and general uniforms.

Best practices of clean room clothing recommend using fabrics appropriate for the industry in which a person works. For example, you would not want personnel who work with biohazards wearing basic clothing suited for a simple processing plant.

Gloves, hats, shoes, jumpsuits are all taken into consideration with each manufacturing facility.

Prepacking medication facilities follow these guidelines also and choose the most protective gear for their employees.

Clean Room Testing and Certification

Choose a prepacking facility that has their clean room tested and goes through a certification process. This means they will have the airflow in their facility tested for visualization, volume and velocity to make sure they meet standards for packing medications.

They will also undergo testing for lights and sounds and how those affect the product. Air exchange rates and filters will be evaluated. In addition, temperature and temperature controls will be tested, as well as the humidity and pressures.

Certification proves to customers that the company’s personnel are following rules and regulations to ensure product safety. It proves the company has followed construction guidelines and that everyone involved is following procedures correctly.

As a physician, you want your patients to receive the best products. If you are dispensing at the point of care, the medicines are a direct reflection of your practices. Meaning, if you supply your patients with highly contaminated pharmaceuticals, you may get the reputation of not being a clean or sterile doctor.

If you provide patients with the most protected and contaminate free substances, you will get the reputation of supplying the best and caring more for your patients.

Find out if your pre-packing company is using a clean room. Do it for your patients.

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