Compounding pharmacy

California Board of Pharmacy Compounding and Hazardous Drugs Regulations – Monitoring Positive and Negative Pressure

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Compliance for Compounding Pharmacies

All compounding pharmacies will be required to comply with the pending general regulatory updates in 16 CCR 1735 and 16 CCR 1751 on January 1, 2017. The California compounding regulations have since been finalized, and can be found here: https://www.pharmacy.ca.gov/laws_regs/1735_ooa_clean.pdf.

As of January 1, 2017, all California sterile compounding pharmacies must be compliant with the most recent laws and regulations. Let’s look at some of these regulations and see how to ensure your sterile compounding pharmacy meets (or exceeds) state guidelines. The specific regulations pertain to monitoring and recording positive and negative pressure as well as temperature and relative humidity (RH):

  • Section 1735.1(a)
  • Section 1735.1(j)
  • Section 1735.1(l)
  • Section 1735.6(2)
  • Section 1751.(4)
  • Section 1751.1(6)[a,b,c]
  • Section 1751.1(8)
  • Section 1751.1(11)[c]
  • Section 1751.3(21)

The above sections outline the proper monitoring and recording of negative and positive air pressure as well as general environmental monitoring and the recording of these variables.

A typical clean room consists of an anteroom (or gowning room) and a sterile room (cleanroom). Maintaining the correct air pressure differential between these two rooms is critical in a compounding pharmacy environment for the safety of cleanroom workers as well as related staff.

Monitoring air pressure and controlling air pressure based on the data monitored are separate initiatives. A California State-compliant clean room monitoring system should include the following:

  1. Ability to monitor negative and positive air pressure differentials between multiple areas of interest.
  2. Chart and record collected monitoring data for quick and effortless retrieval upon state inspection.
  3. Store logged data for prolonged periods of time in an integrated/on-board storage array.
  4. Allow for fast and organized download of collected negative and positive air pressure differential readings.
  5. Have the ability to sample in air pressure differential in intervals set by cleanroom administration, and has the ability to change based on sterile compounding needs.
  6. The ability to chart, and log, temperature (±.05°F), relative humidity (RH) (±3%), and differential pressure (±0.007″ WC)
  7. Additional advantageous accessories to the ideal system would include the ability to send alert notifications via text/SMS to all pharmacy personnel, or phone call alerts with an automated phone dialer.  Having an audible room alarm would be a plus.

In most cases, current technological hurdles prevent compounding pharmacies from possessing an “all-in-one” solution. Buying separate system components to monitor all required variables can be expensive and difficult to integrate.

Solutions

While there are many stand-alone products which, when used in combination, can provide complete compliance, it is preferred in most compounding pharmacies to have a single differential air pressure, temperature and relative humidity monitoring solution. There are very few reputable manufacturers who can accomplish this, and even fewer that offer automatic data logging, remote sensors and USA-based manufacturing, R&D, woith live product support. In fact, a company called “Two Dimensional Instruments, LLC is the only company which offers such a solution. This site (prodataloggers.com) is the only authorized distributor of the TV2 Room Pressure Monitor.

TV2 Room Pressure Monitor- An Introduction

The TV2 Room pressure Monitor is the only all-in-one monitoring solution for positive and negative air differential pressure monitoring, temperature and relative humidity monitoring, automatic data logging, with advanced and automated alerts and USA-based manufacturing & support.

The TV2 Room Pressure Monitor features some of the most comprehensive and secure data acquisition, monitoring and reporting capabilities available. The core chipset/brain of the TV2 Room pressure Monitor is in use and trusted by some of the world’s most highly technical (and demanding) companies such as NASA, Boeing, Northrup Grumman, Lockheed Martin, GE and the Department of Homeland Security.

In it’s second hardware revision and tenth software revision, the TV2 platform is a trusted workhorse in the field of aerospace, academia and other institutions where highly-accurate instrumentation is required. The TV2 Room Pressure Monitor exceeds all California Board of Pharmacy requirements concerning differential air pressure, temperature and relative humidity monitoring. Additionally, the TV2 satisfies all data logging and records-keeping requirements with 21-CFR-11 encrypted data storage.

Other features of the TV2 Room pressure Monitor can be found here: TV2 Room pressure Monitor Features

A product spec sheet can be found here: TV2 Room Pressure Product Spec Sheet

If you want to learn more about an example installation, you can view installation notes here https://www.prodataloggers.com/clean-room-installation-guide/

Finally, if you are considering other brands, see how the TV2 Room Pressure Monitor stacks up against the competition here.

If you want pricing information or to ideas in configuring your product, please visit our store!

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TV2 mounted on wall

Using a Permanent Room Pressure Monitor in a Negative Pressure Isolation Room

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Negative pressure isolation room.

Permanent Room Pressure Monitor

Before a new isolation room is occupied, and after the mechanical contractor has adjusted the airflow quantities as directed by the engineer to ensure that it operates as designed it should not be assumed that it will operate under the same conditions for every more. Mechanical systems do drift out of balance over time so it is important to regularly check that an isolation room is still operating under negative pressure; planning for this should be included in the initial design of the mechanical room.

The most reliable way to monitor negative pressure is to install a permanent electronic room pressure monitor as part of the construction project. When properly selected and installed, a room pressure monitor can provide continuous confirmation of negative pressure across a room boundary. This is in contrast to routine periodic smoke testing, which merely provides an indication of directional airflow at the moment of testing. Continuous monitoring can provide instant notification if the pressurization fails or fluctuates during the day.

A well-constructed pressure room monitor consist of two main components: a wall-mounted panel and one or more sensors. The panel is usually mounted on the corridor wall just outside the isolation room suite and displays the pressure difference in units of ” W.C.

The best type of permanent pressure monitors are those which measure and display the actual air pressure difference between the isolation room and the reference space.  A power supply will be required for the panel.

Pressure differentials across room boundaries can be very small, often in the range of thousandths of an inch. For example, the CDC Guidelines recommend that negative pressure be at least minus 0.001″ W.C. Some devices that measure differential pressure are not accurate to this level. Before specifying or purchasing a room pressure monitor, make sure that the device is capable of accurately and reliably measuring a pressure difference this small.

Direct Room Pressure Monitor

To record a differential pressure, two readings are required: the air pressure in the room and the reference pressure in the corridor. A remote sensor to measure the room pressure is installed in the negative pressure room wall or ceiling with a static port opening in the area being compared. Another sensor measures the air pressure in the corridor. The difference in these two pressure values is the relative room pressurization, which is displayed on the panel.

If there is an anteroom between the isolation room and the corridor, the pressure differential to be measured is the one between the isolation room and the ante room. Or in the best case two differential pressures can be measured and displayed.  One between the room itself and the anteroom and another differential pressure reading between the anteroom and the corridor.

The location of the differential pressure sensor can affect the accuracy of the measurement. They should be installed as close as possible to the isolation room door, but away from drafts. A wire from the panel will run to the actual pressure sensor itself and clear plastic tubing will need to be run from the sensor to the static pressure port in each area.  This tubing will typically be run out of sight inside wall cavities and above the ceiling.

Alarm(s) and Controls

In addition to providing a continuous readout of the pressure difference, the wall panel should include an audible and visual alarm to warn staff when pressurization is lost. The alarm will sound when the measured room pressurization drifts to less than the monitor’s reference pressure value. The reference pressure value is programmed by the user. It will be a value between the steady state pressure differential maintained by the room and zero (neutral pressure). For example, in a room with a steady state pressure differential of minus 0.03″ W.C., the alarm could be programmed to activate when the pressure differential rises to minus 0.001″ W.C. Minus 0.001″ W.C. is the reference pressure value.

The wall panel should also allow staff to program a time delay between loss of pressurization and alarm activation. The time delay will allow staff to enter and leave the room without setting off the alarm. A typical time delay is 45 seconds but could be as much as several minutes. The audible alarm is usually a beeping sound, which will stop when negative pressure is restored or when silenced with a screen touch.

The visual alarm usually consists of a red warning light. Most wall panels also have a green “normal” or “safe” light, which indicates that the monitor is operating and negative pressure is within programmed parameters. The best wall panel displays now show the differential pressure in a green font if the pressure is within ‘safe’ limits and in a red font if the pressure differential falls or rises too high.

Like the audible alarm the visual display will reset once the pressure returns to expected levels, however the max/min indication will remain red indicating that the pressure was too high or low at some point since the last time it was checked.

Max/Min Pressures

The best differential pressure monitors have a max/min feature which continually shows the high and low pressure reached since it as last reviewed.  This ensures that someone is regularly checking, not only the current pressure, but is also aware if an unsafe pressure occurred in the past.

Remote Alarm

In addition to the alarm included on the wall panel, most room pressure monitors include an extra relay to trigger an alarm signal in a remote location, such as the nurses’ station, a central switch board, or the engineering department.  The best pressure monitors can be set to send an email or text alert if an alarm occurs. In some states, for example, the hospital building codes require that negative pressure isolation rooms be equipped with an alarm that annunciates at the room and at a nurses’ station or other suitable location.

Commissioning and Staff Training

The monitor installer’s responsibilities should include verifying the operation of the sensor.  The following should be completed before the room is used to isolate suspected or confirmed infectious TB patients:

  1. Verify that the alarm works. Hold the room door open. After the time delay, the audible and visual alarm should annunciate. The alarm should reset after the “mute” or “reset” button is pressed and/or the door is closed again.
  2. Verify that the monitor is correctly reading the pressure. While the door is held open, the pressure reading should be at or near 0″ W.C.
  3. Instruct staff in monitor usage. The floor staff who depend on the monitor for their safety should feel comfortable using it. They should receive detailed instructions on how the monitor works and how it is.