02-15-2012 01:01 PM - edited 02-15-2012 01:45 PM
Thanks for joining our webinar today, "Top USP 797 Gaps: Results from the 2011 Compliance Survey."
Have a question for Eric or Kate? Please post them here and they will do their best to answer.
02-15-2012 02:53 PM
In listening to the webinar and reviewing the article Kate wrote (which is excellent) on environmental monitoring and sampling: facility-related and personnel-related metrics, I have a fe questions about isolator facilities as it relates to air pressure and velocities, temparture readings and humidity readings. It says in this article, "regardless of the type of engineering, pressure differentials or air velocities must be verified and documented daily." There are pressure gauges on the isolators. These should be documented daily via a paper log, for example? We are not doing this. In addition, both of the isolators (CAI and CACI) are in different rooms under ISO 8 air (we have not been able to reach ISO 7 conditions in the one room) but the isolators do meet the CETA guidelines. My question is this - do these rooms themselves have to been monitored for pressures? We do have the ability to monitor temperatures as we have electronic thermometers in each room but we do not document daily what the temperature is. We do not have the ability to document humidlity but that does not appear to be a USP 797 requirement. Our drug storage devices are electronically monitored through our engineering department. The incubators we use for our fingertip and surface sampling are monitored through the lab who does the incubation for us. Can you clarify the documentation required for air pressure on the isolators, the air pressure in the rooms, and the temperature? Thank you...we are in the middle of enviromental monitoring policy and procedure creation and would like to be able to rectify any deficiencies and put it in our policies. Thanks!
02-16-2012 02:02 PM
Q: What 4 states require no compliance with 797?
The answer is in the table below. Visit http://clinicaliq.com/797-state-survey where additional information is available. Please note the website map is currently being updated and this table is more current than the website. Available on the website are also detailed regulatory information about each state.
02-16-2012 02:05 PM
Q: How do I access the forms they talked about for "Right to Know" for employees handling Hazardous CSPs?
The form can be found on the Pharmacy Purchasing and Products Magazine website where the original study results were published. We provided a link to the original study for you but here it is for your convenience.
Link to original article (which also has a lot of practical tips to compliance after the results section:
Here’s the link to the Hazardous Drug Acknowledgement Form:
Here’s the link to the Gloved Fingertip Sampling Policy and Procedure and Form:
02-16-2012 04:42 PM
Thanks for your kind words PattiK. I believe when I said that pressure differentials/air velocities must be verified and documented daily, I was discussing secondary engineering controls such as buffer and ante areas or rooms. Controlled compounding environments that are constructed with physical walls between the buffer/cleanrooms and the anteroom must maintain a minimum differential positive pressure of 0.02 inches water column between the buffer/cleanroom and the unclassified general pharmacy area. Those pressures must be verified and documented daily.
There is no requirement in the chapter to verify and document the pressures in CAIs daily however it is generally best practice to ascertain that any primary engineering control is working properly and in accordance with manufacturer specifications. CACI’s however are “containment” systems and therefore are required to maintain negative pressure. The Chapter is very clear with regard to the placement of CACIs and states that if a CACI is used outside of a buffer area and it meets the requirements of the chapter (yours does you said), the compounding area into which it is placed must “maintain a minimum negative pressure of 0.01 –inch water column and have a minimum of 12 ACPH. Again, I would refer you to the operator’s manual for your CACI and CAI, but I’m not sure how you can verify that your primary engineering controls are functioning properly without some type of daily verification. Please remember that Chapter <797> sets for the minimum practice and there are many cases where you may decide to do more or to add checks and documentation at potential critical points of failure.
There is no requirement to verify and document temperatures daily except in controlled drug storage areas (often there is some drug stock is kept in the cleanroom). In relation to cleanrooms and anterooms, the temperature is critical to compounder comfort. The chapter states that facilities “provide a comfortable and well-lighted working environment, which typically includes a temperature of 20° or cooler….” Heavily garbed compounders will perspire and be uncomfortable in room temperatures higher than 68°F (20°C) degrees. Ideally, it’s been my finding in practice, that staff are most comfortable with temperatures between 66 and 68°F. Daily monitoring of temps needs to take place in refrigerators, freezers and incubators.
There is no reference to a desirable range for relative humidity in the chapter. Humidity is a consideration in cleanrooms because when humidity is too high, moisture can form on the floor which can cause slip and fall accidents. Obviously moisture may also facilitate bacterial growth. Relative humidity that are too low can cause excess static electricity. Generally a relative humidity between 25-60% will avoid either of these situations.
It is my personal opinion that it is desirable to document the temperature and relative humidity of the cleanroom during dynamic working conditions at least daily. It provides information on the general state of control of controlled environments and provides important data trends over time. That said, however, there is no requirement for temperature monitoring and documentation in non drug storage areas nor is there a requirement for humidity monitoring in the chapter.
02-17-2012 06:57 AM
I have a question about clean room set-up. Can you have one anteroom that services a negative pressure chemotherapy prep area and a positive pressure non-hazardous IV prep area?
02-21-2012 01:01 PM
Yes, you can, however the ISO classification of the ante area needs to be ISO Class 7 since it be serving a negative-pressure ISO Class 7 buffer area.
02-22-2012 02:21 PM
Thanks so much for the clarification. One last question then for you regarding air pressure. We have documentation from our every 6 month room certifications that the room maintains 0.01+ inch of water (negative) and has > 12 ACPH. Does our CACI room have to have an actual air pressure monitoring device so that can be documented daily? I believe the answer is going to be "yes" because right now we only have 6 month documentation. Thanks!
02-23-2012 08:15 AM
The answer is yes (in my opinion).
Please read directly from the chapter: "All hazardous drugs shall be prepared in a BSC 5 or a CACI that meets or exceeds the standards for CACI in this chapter. The ISO Class 5 (see Table 1) BSC or CACI shall be placed in an ISO Class 7 (see Table 1) area that is physically separated (i.e., a different area from other preparation areas) and optimally has not less than 0.01inch water column negative pressure to adjacent positive pressure ISO Class 7 (see Table 1) or better ante-areas, thus providing inward airﬂow to contain any airborne drug. A pressure indicator shall be installed that can be readily monitored for correct room pressurization. The BSC and CACI optimally should be 100% vented to the outside air through HEPA filtration. If a CACI that meets the requirements of this chapter is used outside of a buffer area, the compounding area shall maintain a minimum negative pressure of 0.01-inch water column and have a minimum of 12 ACPH."
Though the chapter states in the section on pressure differentials that the pressure should be read every work shift or at least daily and that is referring to the differential from the buffer to anteroom and then from the ante room to the general prep area, it follows to me that if there's a requirment to maintain negative pressure of 0.01 inch wc, that it is prudent to place a magnahelic gauge and read daily. As I said in the webinar the cost of a magnahelic is about $85 plus labor.
02-23-2012 08:27 AM
YES! You might find it quite helpful to use a copy of the chapter that I have posted on several posts as a reference to answer many of your questions.