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April 2006 HESP Newsletter
Volume 21, Number
4, April 2006
Meeting Notes
Meeting Announcement
Next Meeting: Tuesday, May 2, 2006
Location: American Serbian Club on the South Side
Meeting Sponsor: Mini Tradeshow Event
- Intelligent Electronic Systems -- Tom White
- Hilti -- Scott McDonald
- Parts Source -- Dave Destefano
- Tools -- Kevin Kearney
- Nihon Kohden -- Alan Golombek
- Applied Health Physics -- Ellen Tepreg
- ML Financial Advisor -- Mark Lantz
- Controls Link, Inc. -- Robert Reinhart
- Mobile Air -- Robert Flynn
- Premier Power Solutions -- Lee McCracken
Agenda
| Attitude Adjustment |
5:00 p.m. |
| Buffet |
6:00 p.m. |
| Host Presentation |
6:45 p.m. |
| Business Meeting |
7:30 p.m. |
Business Meeting Minutes
Call to Order: President Dan Procupp called the meeting to order at 6:45 P.M.
Dan introduced our sponsor for the evening, Filtech. Harry Elinski, Jr.
explained current and new federal regulations of USP 797 for clean rooms and
buffer rooms in hospital pharmacies.
Business Meeting: Dan called the meeting to order at 7:45 P.M. The minutes of
the March 2006 meeting were approved as printed. The attendance for this
evening's meeting was as follows: 19 hospital members; 23 associate members;
and 9 guests. The actual count was 59.
Treasurer's Report: Dick Barker -- Dick read the Treasurer's report. It was
approved as read. The 50/50 raffle was drawn. Bruce Saddler of Automated
Entrance Systems Co., Inc. won $71.00.
New Members: William E. Burnett, Director of Engineering and Maintenance, Mon
Valley Hospital; and Frederick Sala, who works at the former SCI-Pittsburgh.
HESP welcomes its new members!
Guests: Two (2) guests introduced themselves tonight: Cindy Barto and Ellen
Teprag, Applied Health Physics. It was a pleasure meeting you ladies! HESP
trusts that you will return and continue to be HESP supporters.
COMMITTEE REPORTS
Education: Michael Bryer -- No Report.
Newsletter: Ron Lukcic -- Ron thanked all of our advertisers. As usual, Ron is
looking for articles of interest and / or humor for the newsletter.
Codes and Regulations: Bill Brooks -- No Report.
ASHE: No Report.
Biomed: Dan Procupp -- No Report.
Membership: Brenda Henwood -- No Report.
Holiday Party: Chuck Froetschel -- Chuck said that we, again, will have a Monte
Carlo theme, plus the addition of Texas Hold em Poker. We are looking at a
tentative date of Friday, December 8th, at the American Serbian Club. More
information to follow. Chuck would, also, be interested in suggestions, ideas
and volunteers for the party committee. See Chuck or look for his contact
information on the back of the newsletter.
Summer Activity: Bruce Saddler -- Bruce reminded us that we have set the date
for the Washington Wild Things game and tailgate party -- Saturday, July 15,
2006. We need to know who will be attending by the 3rd week of June. Look for
information in the mail by mid May. Bruce would, also,appreciate donations of
door prizes from vendors.
Golf Outing: Steve Tarasovic -- Steve reminded us that this year's golf outing
has been set for Thursday, September 14th with an ELEVEN O'CLOCK tee-off time.
This year's outing will be at the Lindenwood Golf Course in Peters Township.
Steve would appreciate donations of door prizes from vendors or anybody.
Web Site/Marketing: Alice Hoffmaster (The Write Design) -- No report. However,
Ron, our Newsletter Editor, reported that the reason for Alice's absence was
due to her father's recent accident. Her father happened (accidentally) to
break both of his legs. HESP wishes the best outcome for Alice's father.
Hospital Engineers Special Projects: No Report.
Old Business: Dan said that there are still a few tables open for next month's
mini trade show. The cost is $300 per table.
New Business: Dan read an invitation from Sherwin Williams for their Pro Show,
set for this Friday April 6th at Heinz Field. They will have lunch at noon.
Deep Discount Items and door prizes. All HESP members are invited.
Adjournment: There being no further business, Dan adjourned the meeting at 8:04
P.M.
Respectfully submitted,
Frank Rutledge, Secretary
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April's Meeting Sponsor
HESP extends its thanks and appreciation to the Harry C. Elinsky, Jr. of
Filtech, Inc.
Synopsis of Presentation by Filtech Inc. April 4, 2006
This evening's presentation was intended to explain the environmental control
requirements of USP <797> to the hospital engineer. Since the publication of USP <797> both hospital engineers and pharmacists have been struggling to update
their facilities. The document offers little guidance to the engineering
community. This evening's presentation was intended to help bridge that gap.
The United States Pharmacopeia (USP) is the official public standards-setting
authority for all prescription and over-the-counter medicines, dietary
supplements, and other healthcare products manufactured and sold in the United
States.
USP <797> is considered to be an official minimum standard for pharmacy sterile
compounding , and it is therefore enforceable by the Food and Drug
Administration (FDA), state boards of pharmacy, boards of health, and other
regulatory agencies.
The intent of USP <797> is to prevent patient harm and increase the quality of
patient care. There are 13 major sections of USP <797>. One of the 13 sections
addresses Environmental Quality and Control.
Engineering controls for USP <797> include primary controls and secondary
controls. Primary controls are point of use controls. Secondary controls are
facility design controls. Both primary and secondary controls employ HEPA
filters and airflow to create air of appropriate cleanliness. Secondary
engineering controls use anteroom and buffer room concepts.
HEPA filters allow control of the airborne particulate level entering the work
zone or cleanroom.
Unidirectional airflow patterns serve to sweep contaminates generated in the
work sites away from the work sites. Non-unidirectional airflow patterns dilute
contaminates by mixing with cleaner air.
Compounded sterile product preparation facilities utilize laminar airflow
workbenches to provide an adequate critical site environment. These primary
engineering controls include horizontal flow clean benches, biological safety
cabinets, and barrier isolators. Primary engineering controls must provide at
least ISO Class 5 quality air per ISO standard 14644-1.
Compounded sterile products must be manipulated in an ISO class 5 environment.
The ISO class 5 environments must be located in a buffer area that is ISO Class
8. (Proposed changes to USP <797> will require a cleaner ISO class 7
environment.)
Barrier isolators, a relatively new concept to the compounded sterile products
industry in the United States, are received consideration as alternatives to
cleanrooms.
General recommendations for this cleanroom design include:
1. HEPA filtration of supply air.
2. A minimum of 30 air changes per hour is usually appropriate.
3. Specific airflow pattern consideration. Location of return air grills is
more important than location of HEPA filtered air supply.
4. Pressurization insures airflow from cleanest area to less clean areas.
Airflow should be from buffer room to ante room to unclassified areas. Room
pressure differentials are normally between 0.02" wg and 0.05" wg.
5. Temperature and humidity requirements normally range between 66
degrees -- 72 degreesF and 30% -- 60% RH.
6. All room surfaces must be non shedding materials. Such as epoxy painted
gypsum walls and ceilings. Cleanroom grade ceiling tiles with anodized
aluminum tee bar grids. Lights with smooth surfaces to facilitate cleaning.
Flooring with no crevices for microorganisms.
Although published just two years ago, significant gaps and shortcoming in USP <797> exist. Among these are addressing of hazardous drugs, improving the air
cleanliness level to ISO class 7 from ISO class 8, and use of barrier isolators.
Anticipated proposed changes are to be published in the US Pharmacopeia in May
or June. A 90 day comment period will allow input from interested parties. The
USP Expert Committee on Sterile Compounding will consider the comments and issue
a revised document.
In the meantime pharmacy personnel are struggling with updating their facilities
and operating methods to comply with the twelve (12) other sections of USP <797>. Legal implications are "murky". The FDA does not directly inspect
compliance but "exercise enforcement discretion" in cases of "misbranded" or "adulterated" products. State boards of Pharmacies also have jurisdiction.
However states boards have mixed acceptance. In Pennsylvania, the Board of
Pharmacy is currently working towards implementation of standards for compounded
sterile products. The board cautions practitioners about possible repercussions
from failing to comply with USP as a standard of acceptable and prevailing
pharmacy practice.
JCAHO will not survey with the specific requirements of USP <797>. JCAHO only surveys its own standards. However JCAHO requires as part of standard MM.8.10
improvement of medication management systems when applicable. JCAHO considers
USP <797> to be an improvement. Gap analysis and compliance plans are required.
Time tables for implementation must be established and be reasonable.
Consequently most facilities are struggling with this new paradigm regarding
compounding sterile products. Implementing what can be done practical appears
most sensible. Waiting for changes to USP <797> before major capital
expenditures is prudent.
In the meantime, should you require assistance with any environmental quality
issue of USP <797> please consider Filtech Inc as a valuable resource.
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Calendar of Events for Upcoming Sponsors
June: Deval -- Topic: Boilers
September: Service Master --Topic: To Be Announced
October: Grainger -- Topic: To Be Announced
If you would
like to be a meeting sponsor in 2006/2007,
please contact Dan
Procupp .
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