2008 ashp summer meeting seattle, washington educational ... · 2008 ashp summer meeting seattle,...

2008 ASHP Summer Meeting Seattle, Washington

Educational Session Abstracts

121 Complying with USP <797>: hoods, isolators, and cleanrooms Kilgore, K.M. The CPI Group, 3333 S Bannock St #740, Englewood, CO 80110, USA. Email: [email protected] Wagner, J.T. Abstract: Standards and regulations give guidance for accomplishing a necessary task but still leave enough flexibility to accommodate different operations. In the case of USP chapter <797>, this flexibility has resulted in different interpretations regarding cleanroom facilities. This presentation will share experiences from early attempts to design and build compliant sterile compounding facilities. Explore the various aspects of engineering controls from the following perspectives:

a. What the standards say b. Good examples of compliance a. Look at multiple effective interpretations of each relevant

section b. Bad examples of compliance a. Look at multiple effective interpretations of each relevant

section c. What type of guidance does an architect need

Learning Objectives:

1. Understand the meaning behind the facility requirements in USP Chapter <797>.

2. Develop strategies for compliance based on both positive and negative experiences of past projects.

3. Communicate effectively with the project architects and engineers. Self-Assessment Questions:

1. (True or False) USP recommends that engineering controls used for hazardous drug compounding be vented to the inside environment.

2. For a Class II Type A2 cabinet to be used for processing drugs that volatilize, what must be done?

© 2008 American Society of Health-System Pharmacists

2008 ASHP Summer Meeting Seattle, Washington

Educational Session Abstracts

a. Use more efficient HEPA filters for the supply air b. Vent the BSC to the outside atmosphere to the outside via a

canopy connection c. Vent the BSC back into the room after HEPA filtration d. Only use the BSC when the front sash is fully closed

3. From the list below, check the cabinet that is NOT a recommended engineering control. a. Class II Type B2 BSC b. Class III BSC c. Compounding Aseptic Containment Isolators d. Class II A1

4. (True or False) The B2 is a non-recirculating, externally vented unidirectional airflow device that provides an ISO class 5 environment.

5. What is typical cleanroom temperature range? (What is typical cleanroom temperature range?) a. 66º F to 69º F b. 66º F to 70º F c. 66º F to 72º F d. 60º F to 69º F

6. (True or False) The facility design should ensure the ability to get components into the primary engineering control, without introducing contamination into the Direct Compounding Area.

7. (True or False) Wipes are often chosen over electric dryers, because of the extensive drying time required for dryers that are designed to reduce contamination.

8. Cleanroom walls are either epoxy coated gypsum board or _________ made of cleanroom compatible materials. a. Non-coated b. Interlocking Panels c. Free-standing Panels d. Interlocking Sheetrock

Answers: 1. False; 2. b; 3. d; 4. True; 5. c; 6. True; 7. True; 8. b


Complying with USP <797>: Hoods, Isolators, and Cleanrooms

Jim Wagner •President, Controlled Environment Consulting

Karl Kilgore AIA, NCARB, President, The CPI Group

Eric Kastango •President, Clinical IQ

Disclaimers

“Although I am a member of the USP Sterile Compounding Committee, I am speaking in my individual capacity and not as a member of the Committee or as a USP representative. The views and opinions presented are entirely my own. They do not necessarily reflect the views of USP, ASHP or any other organization, nor should they be construed as an official explanation or interpretation of <797>.” James Wagner

“I am speaking in my individual capacity. The views and opinionspresented are entirely my own. They do not necessarily reflect the views of USP, ASHP or any other organization, nor should they be construed as an official explanation or interpretation of <797>.” Karl Kilgore


Session objectives

Explain the meaning behind the facility requirements of <797>Develop strategies for compliance that deliver a functional solutionDescribe how to communicate effectively with engineers and architectsExplain how to use performance criteria to hold the design and construction team accountable

Hierarchy

Means to an End

Design criteria important but not as important as the functionality of the operation


Hoods, Isolators, and Cleanrooms: Case Study: Pharmacy Processing and Shipping Facility

Starting point

•Anchor Points

• Existing Building

• Central Ante-room

• Minimal Water and Drains


FLOOR PLAN

CONSIDERATIONS

•Product Flow

•People Flow

•Work Flow

•Sterile Environments

•Efficiency

•Standards



CLEAN ROOM FLOOR PLAN

CONSIDERATIONS

•Work Flow

•Strengths

•Problems


AIR FLOW DIAGRAM

CONSIDERATIONS

•Supply

•Return

•First Air

•Problems


What the standards say

Primary Engineering ControlUnidirectional airflow (laminar flow)

First AirState of Control

Unidirectional airflow

The reality – make it work


Unidirectional airflow

Points of turbulence

Airflow Diffuser

Non Unidirectional airflow


Certification procedures such as those outlined in CAG-003-2006 shall be performed by a qualified individual

Every 6 monthsAfter RelocationWhen AlteredAfter major service to the facility

Certification vs. ValidationUse industry based standards – not “manufacturer criteria”


Certification

Establish “performance (acceptance) criteria”USP <797>CETA CAG-003-2006Facility design criteria

Hold Contractor/manufacturer accountable to performance criteriaPerformance criteria established by

Owner withCertifier, Architect, Engineer

Cleanroom Certification Priorities



Buffer Area parameters – non hazardousISO class 7 during dynamic operating conditions

30 HEPA filtered ACPHSupplied at the ceiling – returned low on the wall50% poss. From PEC

Segregation0.02” – 0.05”w.c. positive ≥ 40 FPM

Temperature≤20˚ C

Appropriate humidity (not specified)35% - 60%

HEPA filter integrity


Ante Area parametersISO class 8 - dynamic operating conditions

ISO class 7 dynamic if serving neg. press. Chemo room30 HEPA filtered ACPH for Class 7

ACPH not specified for ISO Class 8Supplied at the ceiling – returned low on wallTypically no PEC -

Segregation0.02” w.c. negative to non-hazardous buffer area0.01” w.c. positive to hazardous buffer area

Temperature ≤20˚ C

Appropriate humidity (not specified)35% - 60%

HEPA tilter integrity



NEW PROPOSED

CLEAN ROOM FLOOR PLAN

A

CONSIDERATIONS

•Hood Placement

•Depository Room

•Accessibility (door sizes)

•Janitor’s Closet

•View Site-Lines

•Refrigerator Placement


ORIGINAL PLAN

REVISED PLAN


Hoods, Isolators, and CleanroomsCase Study: Pharmacy Processing and Shipping Facility

PROPOSED CLEAN ROOM: FLOOR PLAN

A

CONSIDERATIONS

Air Return

Depository Room

First Air

Janitor’s Closet

Air Flow Section


PROPOSED CLEAN ROOM: FLOOR PLAN A

CONSIDERATIONS

Air ReturnDepository Room

First AirJanitor’s Closet



ORIGINAL PLAN

REVISED PLAN


PROPOSED CLEAN ROOM: FLOOR PLAN B

CONSIDERATIONS

•Hood Placement

•Cost



NEW PROPOSED CLEAN ROOM: FLOOR PLAN B

•KEY POINTS:

•Air Return

•First Air

Air flow 2 - FinalAir flow 1 - Original



Hazardous and non hazardous small operation

Staring point

Anchor points:

•Existing conditions

• Limited space

•Exhaust

•Drains

Hoods, Isolators, and CleanroomsTypical Layout

FLOOR PLAN

CONSIDERATIONS

•Work Flow

•Air Supply

•Air Return

•Efficiency

•Square Footage Needs

•Adaptability



Buffer Area parameters – hazardous applicationsISO class 7 during dynamic operating conditions

30 HEPA filtered ACPHSupplied at the ceiling Care not to interfere with BSC

PEC externally ventedSegregation

0.01” negativeTemperature

≤20˚ CAppropriate humidity (not specified)

35% - 60%HEPA filter integrity

Storage of hazardous drugs12 ACPH, negative pressure

Facility challenges

External venting of PEC for hazardous drug applications

<797>The BSC and CACI optimally should be 100% vented to the outside.

NIOSHDo not use a ventilated cabinet that recirculates air inside the cabinet or exhausts air back into the room environment unless the hazardous drugs in use will not volatilize (evaporate) while they are being handled or after they are captured by the HEPA filter.


Hoods, Isolators, and CleanroomsTypical Layout

FLOOR PLAN

•KEY POINTS:

•Work Flow

•Air Supply

•Air Return

•Efficiency

•Square Footage Needs

•Adaptability

Get what you paid for

This is only a partial list


Facility challenges

Open concept cleanrooms

Must maintain ≥40 FPM across all openings

Summary

In the final analysis, an effective working environment for the purpose of patient safety is the objective. Standards compliance is simply a means to an end.


Complying with USP <797>: Hoods, Isolators, and Cleanrooms

Jim Wagner •President, Controlled Environment Consulting

Karl Kilgore AIA, NCARB, President, The CPI Group

Erik Kastango •President, Clinical IQ


2008 ashp summer meeting seattle, washington educational ... · 2008 ashp summer meeting seattle,...

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