Radiopharmaceutical Regulatory Updates: Stay in the Know · 4. FACILITIES AND ENGINEERING CONTROLS. 4.1 Facility Design and Environmental Controls. 4.2 Creating Areas to Achieve Easily

Annual Meeting & ExpositionSeattle, Washington | March 22-25

Radiopharmaceutical Regulatory Updates: Stay in the Know

James A Ponto, MS, RPh, BCNP, FAPhA

Mr. Ponto is a volunteer member on USP Chemical Medicines Monographs 4 Expert Committee and chair of USP Radiopharmaceutical Compounding Expert Panel

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Disclosures

This presentation is not endorsed by the USP, nor does it represent the views or

opinions of the USP

• Target Audience: Pharmacists• ACPE#: 0202-0000-19-060-L03-P• Activity Type: Knowledge-based

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CPE Information

At the completion of this knowledge-based activity, participants will be able to:• Describe the history and development of USP <825>.• Delineate the various types of radiopharmaceuticals,

processing activities, practice settings, and individuals for which <825> is applicable.

• Discuss one or more specific situations addressed in <825> where there is a balance between standard sterile handling practices and radiation safety considerations. 4

Learning Objectives

1. In which version of USP <797> were radiopharmaceuticals first explicitly recognized as having special characteristics and therefore described some special aseptic handling allowances?A. 2004 original versionB. 2008 first revisionC. 2015 proposed second revisionD. 2018 revised proposed second revision

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Assessment Questions

2. The primary impetus and recommendation for creating a separate USP chapter for radiopharmaceuticals originated from:A. FDAB. Stakeholder community (eg, SNMMI)C. State Boards of PharmacyD. USP Compounding Expert Committee

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3. For which of the following does proposed USP <825> apply?

A. Preparation of adjunct drugs (eg, sincalide) used with radiopharmaceuticals in certain nuclear medicine procedures

B. Compounding non-sterile radiopharmaceuticals in a hospital nuclear medicine department

C. Compounding sterile radiopharmaceuticals in a 503B outsourcing facility

D. Manufacturing sterile radiopharmaceuticals7


4. Related to radiation safety practices, all of the following sterile processing activities are allowed in proposed USP <825>, EXCEPT:A. Storing and eluting a Tc 99m generator in ambient

air if the eluate is used within 12 hours.B. Using a vial shield even though it may block ‘first air’

to the septum.C. Using low-lint absorbent pads in an ISO 5 PEC.D. Wearing ring dosimeters underneath gloves.

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Early days of sterile compounding….

https://www.pexels.com/photo/aircraft-airplane-antique-classic-126627/ 9

https://www.pexels.com/photo/aircraft-airplane-antique-classic-126627/

With growth and complexity, need for “instruction manual”

https://www.pexels.com/photo/binding-books-color-colorful-273034/10

https://www.pexels.com/photo/binding-books-color-colorful-273034/

• 2004: <797> Pharmaceutical Compounding - Sterile Preparations

• 2008: First revision <797>• 2015: Proposed second revision <797> published in

Pharmacopeial Forum (PF) for public comment >8000 comments received from >2500 stakeholders USP determined that significant revision was needed

• 2018: Revised proposed second revision <797> posted on USP web site and published in Pharmacopeial Forum; if public comments are favorable, it will become official December 1, 2019

USP General Chapter <797>

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Sterile compounding now….

https://www.pexels.com/photo/airplane-aircraft-airport-transportation-system-113017/ 12

https://www.pexels.com/photo/airplane-aircraft-airport-transportation-system-113017/

Or if hazardous drugs…. USP <800>

https://www.pexels.com/photo/flight-flying-airplane-jet-40753/ 13

https://www.pexels.com/photo/flight-flying-airplane-jet-40753/

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Radiopharmaceuticals are similar yet different…. Need for a separate “instruction manual”

https://www.pexels.com/photo/air-aircraft-airplane-army-126625/

https://www.pexels.com/photo/air-aircraft-airplane-army-126625/

• 2004: <797> Pharmaceutical Compounding - Sterile Preparations

Radiopharmaceuticals were not explicitly mentioned• 2008: First revision <797>

Added a short section on “Radiopharmaceuticals as CSPs” e.g., Tc 99m generators can be eluted in ISO Class 8 room

• 2015: Proposed second revision <797> published in Pharmacopeial Forum (PF) for public comment

“Radiopharmaceuticals as CSPs” section slightly expanded about 100 comments addressed Radiopharmaceuticals as

CSPs -- all indicated inadequacy of this section15

Radiopharmaceuticals in <797>

Fall 2016 – SNMMI COR developed a white paper entitled USP Public Standards for Compounded Sterile Radiopharmaceuticals: Recommendations from SNMMI Three recommendations from the white paper:

Delineate common practices that are defined as sterile compounding within the practice of nuclear pharmacy

Create a public standard for the preparation, compounding, and dispensing of sterile radiopharmaceuticals with the practice of nuclear pharmacy [i.e., create a new general chapter]

Reinstate an expert committee dedicated to all standards for radiopharmaceuticals [i.e., chapters and monographs]

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SNMMI White Paper

http://snmmi.files.cms-plus.com/SNMMI-USP-Recommendations-Final_2016.pdf

http://snmmi.files.cms-plus.com/SNMMI-USP-Recommendations-Final_2016.pdf

• Held at USP HQ on Feb 1, 2017• Invited participants included representatives from:

- USP Chemical Medicines Monographs 4 Expert Committee- USP Compounding Expert Committee- nuclear pharmacists in hospital, commercial, and academic settings- FDA - SNMMI COR - USP staff

• Practitioner stakeholders were strongly in favor of developing a separate chapter for radiopharmaceutical compounding

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USP Stakeholders Workshop on Radiopharmaceutical Compounding

• After serious discussion and deliberation, in May 2017 the Compounding Expert Committee and USP staff agreed that creation of a new chapter was appropriate

• Scope and Rationale (posted June 1, 2017): http://www.usp.org/usp-nf/notices/825-compounding-radiopharmaceuticals

“The objective of the new General Chapter <825> Compounding—Radiopharmaceuticals is to provide clear and effective USP public standards that meet patient and practitioner needs for compounded sterile radiopharmaceuticals today and in the future. The proposed new general chapter will delineate compounding activities for radiopharmaceuticals and provide standards associated with these activities.”

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Proposed New General Chapter <825> Compounding -Radiopharmaceuticals

http://www.usp.org/usp-nf/notices/825-compounding-radiopharmaceuticals

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Expert Panel Membership, August 2017

David BarnesAllegra DePietroWendy GalbraithFred GattasRichard Green

Brenda Jensen*Ravi Kasliwal #Patricia Kienle*Paul MahanRezaulMannon§

James Ponto†Sara Rothman#

Vivian LovelessSteve Zigler†

† member, Chemical Medicines Monographs 4 Expert Committee* member, Compounding Expert Committee # FDA representative§ Health Canada

USP staff: Domenick Vicchio Ravi RavichandranGerald HsuJames Austgen

• Sept 28, 2017 First face-to-face meeting of Expert Panel • July 27, 2018 Proposed <825> posted on USP website for

public comment http://www.usp.org/compounding/825-download

• Sept-Oct 2018published in Pharmacopeial Forum 44(5)• Oct 10, 2018 open microphone session (webcast)• Nov 30, 2018 public comment period closed• Jun 1, 2019 revised, final <825> to be published in USP-NF• Dec 1, 2019 anticipated official date

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<825> Timeline

http://www.usp.org/compounding/825-download

Harmonized official dates (anticipated December 1, 2019) to avoid gaps or duplication of coverage

• <795> Pharmaceutical Compounding – Nonsterile Preparations

• <797> Pharmaceutical Compounding – Sterile Preparations

• <800> Hazardous Drugs – Handling in Healthcare Settings

• <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging

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Why the tight timeline?

• Describe all various non-manufacturing processing activities for radiopharmaceuticals, not just ‘compounding’

SNMMI COR had suggested “preparation, compounding, and dispensing of sterile radiopharmaceuticals”

Title changed to “Radiopharmaceuticals -- Preparation, Compounding, Dispensing, and Repackaging”

• Include both nonsterile and sterile radiopharmaceuticals• Describe reasonable standards that balance radiation risks

with aseptic handling practices

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<825> Major Objectives

• Add sections important for radiopharmaceuticals, including: preparation with minor deviations extension of manufacturer-suggested use-by times for kit

preparations immediate-use RBC labeling labeling of blood components

• Include some information items to aid in understanding and provide guidance for implementation Recommend future creation of a new informational chapter,

<1825>, for these and other information items

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<825> Major Objectives (cont’d)

• Start with existing documents and modify as necessary and appropriate USP standards (e.g., <797> ) regulatory rules and guidances (e.g., NRC, FDA, CDC, state

boards of pharmacy) other radiopharmaceutical handling guidelines (e.g.,

SNMMI, APhA)

• Although the Expert Panel members were chosen to represent the majority of users, the EP encouraged and welcomed public comment for improvement 24

<825> Development of Content

1. INTRODUCTIONdescribes intent and applicability

“…intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of sterile and nonsterile radiopharmaceuticals for humans and animals that occur as part of state-licensed activities (e.g., the practice of pharmacy and the practice of medicine.)”

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<825> Content

1. INTRODUCTION (cont’d)does not apply to:

• Manufacturing radiopharmaceuticals in drug establishments

• Compounding radiopharmaceuticals in 503B outsourcing facilities

• Preparing PET drugs under USP <823>• Administration to patients• Non-radioactive drugs (e.g., pharmacologic adjuncts)

[<795> or <797>]note: in each of the first three bulleted scenarios, further

processing and manipulation after release falls within the scope of this chapter 26

<825> Content

1. INTRODUCTION (cont’d)applies to all practice settings that perform these

activities, including:• State-licensed nuclear pharmacies• Federal nuclear pharmacy facilities• Healthcare facilities such as nuclear medicine

departments in hospitals and clinics, nuclear cardiology clinics, other specialty clinics

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<825> Content

1. INTRODUCTION (cont’d)applies to all individuals who perform these activities,

including:• Authorized nuclear pharmacists (ANP)• Authorized user physicians (AU)• Individuals under the supervision of an ANP or AU,

such as: Student pharmacists Nuclear pharmacy technicians Nuclear medicine technologists Nuclear medicine technology students Physician residents and trainees 28

<825> Content

1. INTRODUCTION (cont’d)

1.1 Nonsterile Radiopharmaceuticals

1.2 Sterile Radiopharmaceuticals

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<825> Content

2. RADIATION SAFETY CONSIDERATIONSemphasize importance of radiation safety and the need to balance it with aseptic handling practices

2.1 Time2.2 Distance2.3 Shielding (e.g., vial shields that may disrupt first air)2.4 Radiation Contamination Control (e.g., absorbent pads) 30

<825> Content (cont’d)

3. PERSONNEL QUALIFICATIONS, TRAINING, AND HYGIENE3.1 Aseptic Qualifications3.2 Re-evaluation, Retraining, and Requalification3.3 Ancillary Personnel3.4 Hand Hygiene and Garbing for Immediate Use

Preparations3.5 Hand Hygiene and Garbing for Buffer Rooms and

Segregated Radiopharmaceutical Processing Area (extremity radiation dosimeters allowed)

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4. FACILITIES AND ENGINEERING CONTROLS4.1 Facility Design and Environmental Controls4.2 Creating Areas to Achieve Easily Cleanable Conditions4.3 Water Sources4.4 Placement and Movement of Materials4.5 Classified Rooms4.6 Remote Aseptic Processing Involving a Hot-Cell4.7 Environmental Controls 32


5. MICROBIOLOGICAL AIR AND SURFACE MONITORING5.1 General Monitoring Requirements5.2 Monitoring Air Quality for Viable Airborne Particles5.3 Monitoring Surfaces for Viable Particles

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6. CLEANING AND DISINFECTING6.1 Cleaning, Disinfecting, and Sporicidal Agents6.2 Cleaning Supplies6.3 Cleaning and Disinfecting the PEC6.4 Disinfecting Supplies for Classified Rooms and SRPAs6.5 Disinfecting Critical Sites within the PEC6.6 Cleaning and Disinfecting Items from Patient Care Areas 34


7. ASSIGNING BUDTable 7 summarizes maximum BUDs for various radiopharmaceutical processing activities and in various environmental air quality conditions.

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Manipulation PEC SEC BUD (h)

Immediate use - - 1

Direct infusion system, one needle puncture only (e.g., PET patient infusion system, Rb-82 generator)

- - 10

Dispensing, repackaging, preparation, and preparation with minor deviations

ISO Class 5 SRPC 12

Radionuclide generator storage/elution (e.g., non-direct infusion system; Tc-99m or Ga-68)

- SRPC with ISO Class 8 non-viable particle count

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Radionuclide generator storage/elution (e.g., non-direct infusion system; Tc-99m or Ga-68)

- ISO Class 8 or better buffer room with ISO Class 8 or

better anteroom

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Table 7 (cont’d)

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Dispensing, repackaging, preparation, and preparation with minor deviations

ISO Class 5 ISO Class 8 or better buffer room with ISO Class 8 or

better anteroom

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Dispensing, repackaging, preparation, and preparation with minor deviations, and compounding


better anteroom

96

Dispensing, repackaging, preparation, and preparation with minor deviations, and compounding using a nonsterile component and performing sterilization procedure (e.g., filtration with bubble point testing) but without performing Sterility Tests <71> testing


better anteroom

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Table 7 (cont’d)

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Radiolabeled blood components for immediate use [e.g., Tc 99m red blood cells (RBC)]

- - 1

Radiolabeled blood components (e.g., radiolabeledleukocytes)

ISO Class 5BSC

ISO Class 7 or better buffer room with ISO Class 8 or

better anteroom

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7. ASSIGNING BUD (cont’d)Also includes a discussion of issues to be considered in assigning BUDs for radiopharmaceuticals, such as:

• Radiochemical purity• Radionuclidic purity• Age of generator eluate• Number of particles• Specific activity (molar mass)• Container type

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8. DOCUMENTATION8.1 Master Formulation Record8.2 Records for Preparation with Minor

Deviation/Compounding

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9. PREPARATION9.1 Preparation Following Manufacturer Instructions9.2 Preparation with Minor Deviations

(e.g., activity, volume, dilution, heating, radiochemical purity testing methods, filtering)

9.3 Preparation of Radiolabeled Blood Components(e.g., autologous leukocytes)

9.4 Immediate Use of Red Blood Cell Labeling40


10. COMPOUNDING10.1 Compounding Nonsterile Radiopharmaceuticals

(e.g., oral capsules, radiolabeling food)10.2 Compounding Using Conventionally Marketed

Drug Products(e.g., mixing two sterile injections, kit-splitting)

10.3 Sterile Compounding Using a Nonsterile Drug Substance or Components

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11. DISPENSING11.1 Dispensing and Radioassay11.2 Labeling11.3 Direct Infusion Systems11.4 Transporting Generators Between Facilities

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12. REPACKAGING

13. QUALITY ASSURANCE AND QUALITY CONTROL13.1 Notification About and Recall of Out-of-

Specification Dispensed Radiopharmaceuticals13.2 Complaint Handling13.3 Adverse Event Reporting

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GLOSSARY

APPENDICESAppendix 1: Abbreviations [acronyms]Appendix 2: Example Designs for

Radiopharmaceutical Handling

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October 10, 2018• ~ 160 individuals signed up, 109 called in • Information was presented on background and

development of <825>• ~ 60 questions were addressed

Entire open mic webinar was posted on the USP website:https://www.usp.org/sites/default/files/usp/document/our-work/compounding/825-open-mic.pdfhttps://uspevents.webex.com/mw3300/mywebex/nbrDownload.do?siteurl=uspevents

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<825> Open Mic Webinar

https://www.usp.org/sites/default/files/usp/document/our-work/compounding/825-open-mic.pdf

https://uspevents.webex.com/mw3300/mywebex/nbrDownload.do?siteurl=uspevents

Through the comment period ending November 30, 2018:• Number of comments: >1500• Number of commenters (individuals/organizations): >100• Also additional comments from FDA and CDC

All comments have been/will be addressed, and revisions made as appropriate.A commentary of EP’s responses to comments will be made publicly available.

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<825> Public Comments

• Look for final version of <825> to be published in USP-NF June 1, 2019

• Anticipated official date will be 6 months later -- December 1, 2019

• Watch for Updates on USP’s “Standards for Radioactive Articles” web page:http://www.usp.org/chemical-medicines/radioactive-articles

• USP is discussing creating FAQ’s and/or education course for <825>

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What comes next?

http://www.usp.org/chemical-medicines/radioactive-articles


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2. The primary impetus and recommendation for creating a separate USP chapter for radiopharmaceuticals came from:

A. FDAB. Stakeholder community (eg, SNMMI)C. State Boards of PharmacyD. USP Compounding Expert Committee

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2. The primary impetus and recommendation for creating a separate USP chapter for radiopharmaceuticals came from:

A. FDAB. Stakeholder community (eg, SNMMI)C. State Boards of PharmacyD. USP Compounding Expert Committee

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D. Manufacturing sterile radiopharmaceuticals 52






D. Manufacturing sterile radiopharmaceuticals 53


4. Related to radiation safety practices, all of the following sterile processing activities are allowed in proposed USP <825>, EXCEPT:

A. Storing and eluting a Tc 99m generator in ambient air if the eluate is used within 12 hours.

B. Using a vial shield even though it may block ‘first air’ to the septum.

C. Using low-lint absorbent pads in an ISO 5 PEC.D. Wearing ring dosimeters underneath gloves.

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4. Related to radiation safety practices, all of the following sterile processing activities are allowed in proposed USP <825>, EXCEPT:

A. Storing and eluting a Tc 99m generator in ambient air if the eluate is used within 12 hours.

B. Using a vial shield even though it may block ‘first air’ to the septum.

C. Using low-lint absorbent pads in an ISO 5 PEC.D. Wearing ring dosimeters underneath gloves.

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Questions/Discussion

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THANK YOU

Compounding and Repackaging Radiopharmaceuticals

Sara Rothman, MPHSenior Policy Advisor

Office of Unapproved Drugs and Labeling ComplianceFDA/CDER Office of Compliance

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Disclosures• Sara Rothman declares no financial disclosures.

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Guidance Documents• Compounding and Repackaging of Radiopharmaceuticals by State-Licensed

Nuclear Pharmacies and Federal Facilities• Draft issued December 2016

• 29 comments submitted• Final issued September 2018

• Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities

• Draft issued December 2016• 3 comments submitted

• Final issued September 2018

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Policy ObjectivesFDA’s policies on compounding of radiopharmaceuticals aim to:• Preserve access to compounded and repackaged radiopharmaceuticals for

patients whose medical needs cannot be met by an FDA-approved radiopharmaceutical.

• Reduce the risks of safety and quality concerns associated with these products.

• Prevent inappropriate compounding of radiopharmaceuticals that undermines the drug approval process.

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Background—Statutory Framework• Under the FD&C Act, radiopharmaceuticals, including compounded and

repackaged radiopharmaceuticals, are generally subject to all requirements of the Act related to the production of drugs, including:

• New drug approval requirements (section 505)• Labeling with adequate directions for use (section 502(f)(1))• Current good manufacturing practice (CGMP) requirements (section 501(a)(2)(B))

• Note, however, exemptions available to radiopharmaceuticals compounded by outsourcing facilities.

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Background—Statutory Framework• Section 503A

• While section 503A of the FD&C Act exempts certain compounded drugs from those requirements, the exemptions do not apply to compounded radiopharmaceuticals:

• “This section shall not apply to . . . radiopharmaceuticals.” Section 503A(d) of the FD&C Act.

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Background—Statutory Framework• Section 503B

• Section 503B does not contain similar language excluding radiopharmaceuticals from its scope.

• FDA has determined that compounded radiopharmaceuticals can qualify for the exemptions described in section 503B if its conditions are met.

• Specifically, a radiopharmaceutical compounded by an outsourcing facility in accordance with the conditions in section 503B is exempt from:

• New drug approval requirements (section 505)• Labeling with adequate directions for use (section 502(f)(1))

• Radiopharmaceuticals compounded by outsourcing facilities remain subject to CGMP requirements in section 501(a)(2)(B) of the FD&C Act.

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Policy Objectives—Access• FDA recognizes that entities, including nuclear pharmacies, sometimes

compound radiopharmaceuticals using bulk drug substances or FDA-approved drugs

• For example:• Compounding from bulk in drug shortage situations.• Manipulating an FDA-approved drug using step-by-step instructions that differ from

those of the approved drug to accommodate advances in technology.• Increasing the radioactivity of an approved radiopharmaceutical to accommodate a

patient who lives farther away.

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Policy Objectives—Safety and Quality• Under certain circumstances, such compounding can serve an important

need for patients.• However, it is also higher risk. For example:

• No premarket review of the compounded drug is conducted to ensure that the formulation being administered is safe and effective.

• Lack of CGMP compliance can increase the potential for quality concerns, such as inadvertent contamination.

• It is important that such compounding be done under appropriate conditions that balance patient access with patient safety protections.

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Policy Objectives—Integrity of the Drug Approval Process

• Stakeholders have advised FDA of certain compounders that may have been compounding from bulk drug substances radiopharmaceuticals that were similar to FDA-approved radiopharmaceuticals for patients whose needs may have been met by the approved products.

• Such compounding both undermines the drug approval process and unnecessarily exposes patients to the risks associated with unapproved drugs.

• It is important that any policy that provides for compounding of radiopharmaceuticals, particularly from bulk drug substances, limit such compounding to circumstances in which the approved product would not meet patients’ medical needs.

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Guidance for Entities Other than Outsourcing Facilities

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Terminology• What is compounding?

• No statutory definition of “compounding” of radiopharmaceuticals because they are excluded from section 503A.

• For purposes of this guidance: “FDA regards compounding as the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.”

• Guidance describes two types of compounding:• Compounding that involves manipulations other than “minor deviations”• Compounding that is limited to “minor deviations”

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Terminology• Minor deviations

• Not a statutory term; developed for purposes of this guidance based on stakeholder input

• For purposes of this guidance, a minor deviation is a “change from the approved labeling in radioactivity, volume, and/or the step-by-step procedures that does not adversely affect the quality of the product made when compounding the radiopharmaceutical from an FDA-approved drug product in a patient-ready dose.”

• Manipulations other than minor deviations• More significant deviations from the approved labeling; or• Compounding a radiopharmaceutical from a bulk drug substance.

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Terminology• Repackaging

• “FDA regards repackaging as the act of removing an FDA-approved radiopharmaceutical from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the product.”

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PolicyGuidance describes the conditions under which FDA does not intend to take action for violations of:

• New drug approval requirements (section 505),• Labeling with adequate directions for use (section 502(f)(1)), and• CGMP requirements (section 501(a)(2)(B).

When a state-licensed nuclear pharmacy or federal facility compounds or repackages radiopharmaceuticals.

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Conditions• Two sets of conditions:

• Compounding that involves manipulations other than minor deviations.• Compounding that constitutes minor deviations, and repackaging.

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Conditions—Other than Minor Deviations• Pharmacist supervision and state or NRC license• Receipt of valid prescriptions for individually identified patients

• Compounding (but not distribution) before the receipt of a prescription.• Compounding after the receipt of a prescription.

• Bulk drug substances used in compounding• Complying with a United States Pharmacopeia (USP) or National Formulary

monograph.• Source of bulk drug substances and certificate of analysis.

• Inactive ingredients

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Conditions—Other than Minor Deviations

• Compliance with USP chapter on pharmacy compounding.• List of drugs that have been withdrawn or removed from

the market for reasons of safety or effectiveness.• Compounded radiopharmaceuticals that are essentially

copies of an approved radiopharmaceutical.• List of drugs that present demonstrable difficulties for

compounding.• Wholesaling condition.• Compliance with state requirements.• Compliance with NRC requirements.

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Conditions—Minor Deviations and Repackaging

• Compounding or repackaging using only an FDA-approved drug product (and not a bulk drug substance).

• Pharmacist supervision and facility has a state or NRC license.

• Compliance with USP chapter on pharmacy compounding.• Compliance with state requirements.• Compliance with NRC requirements.• Wholesaling condition.

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Guidance for Outsourcing Facilities

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Terminology• Compounding—statutory definition in section 503B:

• “The combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.”

• Repackaging • “Act of taking a finished drug product, including a radiopharmaceutical, from the

container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug.”

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Terminology• Outsourcing facility—statutory definition in section 503B:

• Facility at one geographic location or address that is engaged in the compounding of sterile drugs;

• Has elected to register as an outsourcing facility; • Complies with all of the requirements of section 503B;• Is not required to be a licensed pharmacy; and• May or may not obtain prescriptions for identified individual patients.

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Policy—Compounding • A radiopharmaceutical compounded by an outsourcing facility is exempt

from new drug approval and labeling with adequate directions for use requirements if all of the conditions of section 503B are met.

• Guidance describes specific policies applicable only to the compounding of radiopharmaceuticals, with respect to:

• Bulk drug substances used in compounding, and• Compounding radiopharmaceuticals that are essentially copies of approved

radiopharmaceuticals.

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Compounding—Bulk Drug Substances• Bulk drug substances used in compounding under section 503B must either

(1) be used to compound a drug that appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing, or (2) appear on a list developed by FDA of bulk drug substances that can be used in compounding because there is a clinical need (“bulks list”).

• Compounders should refer to FDA’s guidance, Interim Policy for Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, for FDA’s policy regarding the use of bulk drug substances in compounding while the bulks list is being developed.

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Compounding—Essentially a Copy• Under section 503B, a drug cannot qualify for the exemptions under 503B if

it is essentially a copy of one or more approved drugs.• A compounded radiopharmaceutical prepared with only minor deviations

may meet the definition of essentially a copy because the differences from the approved drug are minimal. However, these differences may be clinically important.

• Therefore, the guidance describes conditions under which the Agency doesnot intend to take action with respect to the copies provision of section 503B in the context of minor deviations.

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Policy—Repackaging • The exemptions in section 503B are available to compounded drugs, but

not to repackaged drugs.• Repackaged radiopharmaceuticals are generally subject to all requirements

of the Act applicable to the production of drugs.• The guidance describes the conditions under which FDA does not intend to

take action for violations of the following sections of the FD&C Act when an outsourcing facility repackages radiopharmaceuticals:

• New drug approval requirements (section 505).• Labeling with adequate directions for use (section 502(f)(1)).

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Conditions—Repackaging • Product being repackaged is an FDA-approved drug.• Pharmacist supervision and facility has state or NRC licensure.• Compliance with CGMP requirements.• List of drugs that have been withdrawn or removed from the market for reasons of

safety or effectiveness.• Wholesaling condition.• Compliance with state requirements.• Compliance with NRC requirements.• Labeling.• Drug product reporting.• Adverse event reporting.

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Examples of Comments on the Draft Guidances

• Commenters requested clarification on:• Applicability of the guidance to certain settings and entities,

including:• Nuclear medicine physicians/supervised designees;• Hospital-based nuclear medicine departments; and• Nuclear medicine clinics.

• Beyond-use dates applicable to compounded radiopharmaceuticals.

• “Essentially a copy” condition.• “Minor deviations.”

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Examples of Revisions Made in Response to Comments

Guidance for entities other than outsourcing facilities: • Scope revised to: “State-licensed nuclear pharmacies, Federal

facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State”

• Clarifying condition concerning beyond-use date• Removed “strength” factor from “essentially a copy”

condition

Annual Meeting & ExpositionSeattle, Washington | March 22-25

Special Considerations for Cleaning, Disinfection & Sporicidal Use Within a USP 825 Compliant FacilityKenneth S. Latta, BS, RPh, FIACP, FACAVice President – Design & Regulatory ComplianceProPharma CleanRooms, LLCPresident & CEOHealth System Consulting Group, LLC

• Nothing to disclose

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Disclosures

• Understand the difference between the Sporicidal agent used monthly and the Cleaning & Disinfecting agents.

• Differentiate the Daily Cleaning & Disinfection tasks from the Monthly tasks.

• Describe the appropriate requirements for materials utilized in the Cleaning & Disinfection process.

• Recognize the importance of the disinfection process while understanding the need for minimizing radiation exposure.

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Learning Objectives

1. Surface Sporicidal Disinfectant agents tend to be:A. Strong OxidizersB. Quaternary AmmoniumsC. Phenolic agentsD. Alcohols (Isopropyl & Ethanol)

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2. In order to pass materials into the PEC, one must wipe materials with a nonlinting wipe saturated with:

A. Isopropyl Alcohol 70%B. Hydrogen Peroxide 6% or 3%C. Sterile solution that is a Non-residue DisinfectantD. Surface Sporicidal Disinfectant

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3. Daily Cleaning & Disinfection includes:A. PECs & Equipment inside PECs, Work surfaces outside the PECs, Floors, & Sink

(if applicable)B. Ceilings, Walls, & Storage AreasC. Hot Cells ( All Interior Surfaces, PECs & Equipment within a Hot CellD. Both A & C

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4. Absorption of Cleaning & Disinfection Agents with subsequent radiation exposure might be limited by:

A. Sterile Chemotherapy SleevesB. Tyvek CoverallC. N95 maskD. Surgical mask

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• 100,000 particles/cu ft/min • Person sitting motionless

• 2,500,000 particles/cu ft/min• Person sitting down or standing up

• 10,000,000 particles/cu ft/min • Person walking • Creates a plume 28 ft behind walker

• Billions of particles/cu ft/min • Open, non-airlocked door

• Think “Pigpen” from Charlie Brown comics• A gowned body still creates particle

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People as a Source of Contamination

Particles ≥ 0.3 µm Emitted per Minute in Garment IndicatedPersonnel

ActivitySnap

SmockStandardCoverall

Two-PieceCoverall

Tyvek Coverall

MembraneCoverall

No Movement 100,000 10,000 4,000 1,000 10

Light Movement 500,000 50,000 20,000 5,000 50

Heavy Movement 1,000,000 100,000 40,000 10,000 100

Change Position 2,500,000 250,000 100,000 25,000 250

Slow Walk 5,000,000 500,000 200,000 50,000 500

Fast Walk 10,000,000 1,000,000 400,000 100,000 1,000

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Garb vs Particulate Containment

Source: Encyclopedia of Clean Rooms, Bio-Clean Rooms, Aseptic Areas, Dr Phillip Austin, PE, 2000Note: Light/Heavy movement refer to partial body movement (motioning with arms, tapping toes, etc.) Change of position refers to whole body motion (standing up, sitting down, etc.)

• Personnel must don the following garb: • Shoe covers, head/hair covers, face mask • Order that eliminates the greatest risk of contamination (e.g., dirtiest to cleanest) • Defined in facility procedures

• Wash hands for 30 sec then waterless alcohol• Don a low-lint gown with sleeves that fit snugly around the wrists and

enclosed at the neck • e.g., solid front with back covered and secured, or fastened or zippered up to the

neck in front

• Disposable gowns are preferred. • If reusable gowns are used, they must be laundered daily. • All single use 95

Garbing – USP 825Temp Below 25º C (77ºF) & Humidity Below 60%

• Cleaning• Removes contamination from the surface

• Sanitization• Attempts to destroy viable cells on the surface

• Sanitization without cleaning - Akin to Brushing Teeth vs Mouthwash• Must remove residue in order to allow the sanitizers to be effective• Cleaning prepares a surface for disinfection

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Cleaning vs Sanitization

Becker J Cleanroom Cleaning vs Disinfection Controlled Environments V12 (2) 2009 pg 9-13

• Removal of particulates, microbes & residue• Requires that a non-destructive mechanical action be applied to

loosen and remove organic and inorganic residue from the area• “Elbow Grease” in the South• Walls & Ceilings & Vertical Surfaces - loosened and rinsed to the

floor. • Subsequently, the dirtied solution on the floor is collected and

removed• Ensure that cleaning solution does not become dirty and is

changed if necessary

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Cleaning


• Saturation & penetration of the cell wall of an organism by a chemical agent

• Concentration Gradient - Takes Time• Contact time – organism must remain wetted for specific time by

agent in order to kill• Depends upon temperature, surface, and disburden of the surface,

existent soil load, concentration of the chemical agent, and pH.• Keeping the surface wetted for five to ten minutes ordinarily• Must follow Manufacturer’s Guidelines

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Disinfection


• Sterilants (Surface Sporicidal Disinfectants)• Can kill all microbes, spores & viruses – given enough time• Glutaraldehyde, Hydrogen Peroxide/Peracetic Acid, Chlorine Dioxide,

Acidified Sodium Hypochlorite (Activated), Vaporized Hydrogen Peroxide

• High Level Disinfectants• Kill all viruses & vegetative (growing) cells• May not kill Endospores reliably• Sodium Hypochlorite, Hydrogen Peroxide (3% vs 6%?)

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Classes of Disinfectants

CAG-004-2007 CETA Application Guide for the use of Surface Decontaminants in Biosafety Cabinets

• Intermediate-Level Disinfectants• Destroy all vegetative (growing) cells including Mycobacteria, fungi,

and most, but not all viruses• Can not kill Endospores• Isopropyl Alcohol 70% & Phenolics

• Low-Level (General Purpose) Disinfectants• Destroy all vegetative bacteria, except mycobacteria, fungi & non-

enveloped viruses• Quaternary Ammoniums & Ethanol

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Classes of Disinfectants

CAG-004-2007 CETA Application Guide for the use of Surface Decontaminants in Biosafety Cabinets

• “The surfaces … in the classified room must be smooth, impervious, free from cracks and crevices, and non-shedding”

• “Ceilings, walls, floors, doors, door frames, fixtures, shelving, work surfaces, counters, & cabinets”

• “Easily cleaned and disinfected”• “Minimize spaces in which microorganisms & other contaminants can

accumulate.”• “Surfaces should be resistant to damage by cleaning agents,

disinfectants, and tools used to clean.”

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Facility Design Considerations

• “Junctures between the ceiling and the walls and between the wall and the floor must be sealed to eliminate cracks and crevices where dirt can accumulate.”

• “If ceilings consist of inlaid panels, the panels must be caulked or otherwise sealed and secured around each panel to seal them to the support frame.”

• “Ceiling panels must be washable and soil resistant, designed for use in a clean room environment.”

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• Walls must be constructed of, or may be covered with, durable material (e.g., epoxy-painted walls or heavy-gauge polymer) and the integrity of the surface must be maintained.

• Panels must be joined together and sealed to each other and the support structure.

• Floors must be smooth, sealed (e.g., continuous, welded seams), and impervious.

• Floors must include coving to the sidewall.

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• Classified rooms should minimize dust-collecting overhangs such as utility pipes and ledges such as windowsills.

• If overhangs or ledges are present, they must be easily cleanable. • The exterior lens surface of ceiling light fixtures must be smooth,

mounted flush, and sealed. • Any other penetrations through the ceiling or walls must be sealed.

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• “Cleaning and disinfecting are important because surfaces in classified areas and SRPAs are a potential source of microbial contamination of sterile radiopharmaceuticals.”

• “Process of cleaning involves removing organic and inorganic materials from surfaces”

• Manual or mechanical process and• Cleaning agent

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USP <825> Section 6: Cleaning & Disinfecting

• “Process of disinfecting involves destruction of microorganisms, usually with a chemical agent.”

• “Surfaces must be cleaned prior to being disinfected unless an Environmental Protection Agency (EPA)-registered one-step disinfectant cleaner is used”

• “Some EPA-registered one-step disinfectant cleaners may have sporicidal properties.”

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USP <825> Section 6: Cleaning & Disinfecting

• “Radioactive decontamination is the act of reducing or removing radioactivity”

• “Must be balanced with the risk of spreading radioactive contamination.”

• “At times the best approach may be to shield the area until the radiation exposure levels are lower”

• “This balance must be specified in SOPs (e.g., trigger levels for safe cleaning)”

• “PEC should be checked for radioactive contamination prior to cleaning and disinfecting to prevent spreading radioactive contamination in the PEC”

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Radioactivity Effect on Cleaning & Disinfecting

• All cleaning and disinfecting activities must be performed by:• Trained • Appropriately garbed personnel • Using facility-approved agents• Procedures that Must be described in written SOPs

• Cleaning must be performed in the direction of clean to dirty areas• Established SOPs Must establish

• frequency, • method(s), and • location(s) of cleaning • disinfection agent use must be established in written SOPs

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Cleaning & Disinfecting Training, Process & Documentation

• Based in accordance with • Manufacturer’s instructions • Sound microbiological cleaning techniques when unavailable• Must be followed by all cleaning personnel

• Manufacturer’s direction or published data for the minimum contact time must be followed for the cleaning, disinfecting, and sporicidal agents used.

• All cleaning and disinfecting activities must be documented.

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Cleaning & Disinfecting Training, Process & Documentation

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BSC Documentation Example - NonHazardousBiological Safety Cabinet #1

a) Soak nonlinting wipe and/or mop with solution & wipe the upper exterior of the BSC ensuring saturation. Resaturate wipe and/or mop as needed DS/DM

i) Soak nonlinting wipe and/or mop with Surface Sporicidal Disinfectant/Oxidizer & wipe the vent collar, front, top, sides and back of the BSC ensuring saturation. Resaturate wipe and/or mop as needed DS/DM

ii) Ensure 5 minute contact time DS/DMiii) Soak nonlinting wipe and/or mop with Sterile Isopropyl Alcohol 70% & wipe the vent collar, front, top,

sides and back of the BSC ensuring saturation. Resaturate wipe and/or mop as needed DS/DMb) Soak nonlinting wipe with solution & wipe the underside of the BSC unit ensuring saturation. Resaturate

wipe as needed. DS/DMi) Soak nonlinting wipe and/or mop with Surface Sporicidal Disinfectant/Oxidizer & wipe the legs, bottom

and supports of the BSC ensuring saturation. Resaturate wipe and/or mop as needed DS/DMii) Ensure 5 minute contact time DS/DMiii) Soak nonlinting wipe and/or mop with Sterile Isopropyl Alcohol 70% & wipe the legs, bottom and

supports of the BSC ensuring saturation. Resaturate wipe and/or mop as needed DS/DMc) Soak nonlinting wipe with Surface Sporicidal Disinfectant/Oxidizer & wipe the inside of the BSC ensuring

saturation. Resaturate wipe as needed. DS/DMi) Wipe the inside ceiling of the BSC with Surface Sporicidal Disinfectant/Oxidizer DS/DMii) Wipe inside back wall of the BSC with Surface Sporicidal Disinfectant/Oxidizer DS/DMiii) Wipe inside sides of the BSC with Surface Sporicidal Disinfectant/Oxidizer DS/DMiv) Wipe Insde IV rod and any hangers with Surface Sporicidal Disinfectant/Oxidizer DS/DMv) Wipe Insde floor with Surface Sporicidal Disinfectant/Oxidizer DS/DMvi) Remove floor, vent guard, & supports & Wipe insde floor & sides with Surface Sporicidal

Disinfectant/Oxidizer DS/DMvii) Wipe the underside of the floor, both sides of the supports & vent guard with Surface Sporicidal

Disinfectant/Oxidizer DS/DMd) Ensure 5 minute contact time DS/DMe) Soak nonlinting wipe with Sterile Isopropyl Alcohol 70% solution & wipe the inside of the BSC ensuring

saturation. Resaturate wipe as needed. DS/DMi) Wipe the inside ceiling of the BSC with Sterile Isopropyl Alcohol 70% solution DS/DMii) Wipe inside back wall of the BSC with Sterile Isopropyl Alcohol 70% solution DS/DMiii) Wipe inside sides of the BSC with Sterile Isopropyl Alcohol 70% solution DS/DMiv) Wipe Insde IV rod and any hangers with Sterile Isopropyl Alcohol 70% solution DS/DMv) Wipe Insde floor with Sterile Isopropyl Alcohol 70% solution DS/DMvi) Wipe both sides of floor, vent guard, & supports & Wipe insde floor & sides with Isopropyl Alcohol 70%

solution and replace into the BSC DS/DM

Site Cleaning Disinfection Sporicidal

Surfaces of Sink(s) Daily Daily Monthly

Hot-cells (all interior surfaces) Daily Daily Monthly

Work Surfaces Outside the PEC Daily Daily Monthly

Floors Daily Daily Monthly

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Frequency

Site Cleaning Disinfection Sporicidal

Wall(s), door(s), door frame(s), and other fixtures

Monthly Monthly Monthly

Ceiling(s) Monthly Monthly Monthly

Storage shelving & storage bins Monthly Monthly Monthly

• Prior to performing sterile processing of radiopharmaceuticals on each day that activities are carried out, the walls, bars, torso shield and any exposed surface of equipment inside the PEC to the extent possible as specified by the equipment manufacturer or the assessment of a trained microbiologist or industrial hygienist. Radioactive contamination may be shielded with appropriate temporary material, providing the material is covered with low-lint absorbent pads or has equivalent low-shedding properties.

• Bold is for PECs & Equipment inside the PECs• Sporicidal Monthly

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Frequency – CleaningPECs & Equipment Inside the PECsPEC & Equipment Within a PEC Located in a Hot-Cell

• Prior to performing sterile processing of radiopharmaceuticals on each day that activities are carried out, exposed surfaces of the equipment should be disinfected to the extent possible as specified by the equipment manufacturer or the assessment of a trained microbiologist or industrial hygienist and should be specified by SOPs. When used, remove low- lint absorbent pads and survey the PEC for radioactive contamination prior to disinfecting. Replace with new pads after disinfecting or as required after spills.

• Sporicidal Monthly

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Frequency – DisinfectingPECs & Equipment Inside the PECsPEC & Equipment Within a PEC Located in a Hot-Cell

• Cleaning and disinfecting agents must be selected and used with careful consideration of:

• Compatibilities, • Effectiveness, and • Inappropriate or toxic residues or fumes. • Anti-microbial activity, • Inactivation by organic matter, • Residue, • Shelf life, • Preparation requirements of the agent, and • Suitability for surfaces being disinfected

• Refer to: Disinfectants and Antiseptics 〈1072〉114

6.1 Cleaning, Disinfecting, and Sporicidal Agents

• After the disinfectant is applied and wiped on the surface to be disinfected, the disinfectant must be allowed to dwell for the minimum contact time specified by the manufacturer, during which time the surface cannot be disturbed.

• Sporicidal agents, shown to be effective against Bacillus species, must be used at least monthly to disinfect all surfaces in classified rooms and SRPAs.

• Hydrogen Peroxide/Peracetic Acid• Sodium Hypochlorite

• The disinfecting agents (e.g., sterile 70% IPA) used in the ISO Class 5 PEC must be sterile. See Table 6 for a summary of the purpose of the cleaning disinfectant and sporicidal agents.

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6.1 Cleaning, Disinfecting, and Sporicidal Agents

Type of Agent

Purpose

Cleaning Agent

An agent for the removal of residues (e.g., dirt, debris, microbes, &residual drugs or chemicals) from surfaces.

Disinfecting Agent

A chemical or physical agent used on inanimate surfaces and objects to destroy fungi, viruses, and bacteria. Sporicidal disinfectant agents are considered a special class of disinfectants that also are effective against bacterial endospores.

Sporicidal Agent

A chemical or physical agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms.

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Table 6. Purpose of Cleaning, Disinfecting, & Sporicidal Agents

• All cleaning supplies MUST be Low Lint • (e.g., wipers, sponges, and mop heads) • Exception of tool handles and holders

• Wipes, sponges, and mop heads • Should be disposable. • MUST be Discarded after each Cleaning activity if disposable

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6.2 Cleaning Supplies

• Reusable cleaning tools MUST be: • Made of cleanable materials (e.g., no wooden handles) • Cleaned before and after each use. • Dedicated for use in the classified rooms or SRPAs • Not be removed from these areas except for disposal • Discarded after an appropriate amount of time, to be determined

based on the condition of the tools. • Dispose of cleaning supplies in a manner that minimizes the potential for

dispersing particulates into the air • (e.g., with minimal agitation, away from work surfaces).

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6.2 Cleaning Supplies

• 360 degree swivel head• Velcro attachment• 9 “ x 5 “ mop head• Two different thicknesses• Washable • Can Autoclave• Slip covers available• Telescoping pole

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Wall & Ceiling Mopping SystemsMicronova PilloMop

https://www.absolutesci.com/store/shopexd.asp?id=20942

• ContecVertiClean Max

• Lightweight Extension Pole

• Snap on Head• Aluminum vs

Stainless Steel

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Wall & Ceiling Mopping Systems VertiKlean™ MAX™ Mopping Systems

• Sealed Edge Available

• Sterile or NonSterile

• Medium Head -12.8 x 4.3 in. (32 x 11cm)

• Large Head

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Wall & Ceiling Mopping Systems VertiKlean™ MAX™ Mopping Systems

• Replaceable covers• Does not hold much fluid• Wide – 15” x 8”• Difficult to get around

fixtures• Can Autoclave• Sponge pad available to

increase fluid capacity

122

Floor Mopping SystemsAlphaMop

• Sterile & NonSterile heads• 16 x 5 in. (41 x 13 cm)• Autoclavable• Available in Stainless Steel

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Floor Mopping SystemsQuickTask™ system

https://images.search.yahoo.com/images/view;_ylt=AwrExlR3tTxcnxEAStg2nIlQ;_ylu=X3oDMTIzNTFnb2EzBHNlYwNzcgRzbGsDaW1nBG9pZANjMzM5NjQzY2Y3YzVjNDJmZWU2NDcxYWNiYzdhZWRmZQRncG9zAzc2BGl0A2Jpbmc-?.origin=&back=https://images.search.yahoo.com/yhs/search?p=Contec+sterile+head+pictures&fr=yhs-rotz-001&hsimp=yhs-001&hspart=rotz&nost=1&imgurl=https://assets.fishersci.com/TFS-Assets/CCG/product-images/F301443%7Ep.eps-650.jpg&tab=organic&ri=76&w=514&h=341&imgurl=www.contechealthcare.com/files/images/HCPM5001_2740_MicroCinch.jpg&rurl=http://www.contechealthcare.com/&size=30.7KB&name=Hospital+&+Pharmacy+Cleaning+Supplies+for+Infection+Control&p=Contec+sterile+head+pictures&oid=c339643cf7c5c42fee6471acbc7aedfe&fr2=&fr=yhs-rotz-001&tt=Hospital+&+Pharmacy+Cleaning+Supplies+for+Infection+Control&b=61&ni=56&no=76&ts=&tab=organic&sigr=110rlaouq&sigb=17kvaf9t1&sigi=122vk4fd3&sigt=11rmj54sf&sign=11rmj54sf&.crumb=r15pYAKDWyo&fr=yhs-rotz-001&hsimp=yhs-001&hspart=rotz

• Double sided• Elaborate systems• Double bucket

124

Bucket Systems

• Saturate via Dip vs Pour onto Mop or Wipe vs Spray & Wipe

• Paint Pails vs Disposable• Double Sided Bucket

125

Cost Effective Cleaning Systems

• Polypropylene/cellulose blend• Water Absorbent• Single Ply- Rugged, Better for

Scrubbing -12” x 12”• Double Ply – More Solution,

Less Rugged – 11” x 12”• Great for drying hands &

forearms• SIPA wipe to remove residue

126

Wipes

• For hard to reach areas• 17” pole• 7.5 inch x 2.75 inch heads• Sterile or nonsterile• Presaturated IPA 70%

127

EasyReach

128

6.3 Cleaning & Disinfecting the PEC

• PEC with removable work tray, • MUST be Cleaned & Disinfected at least Monthly• All sides of the work tray • Area underneath the work

• 1) Apply a cleaning agent (e.g., EPA-registered, one-step disinfectant cleaner)

• 2) Disinfect with a sterile disinfectant (e.g., sterile 70% IPA) • 3) Allow the surface to dry completely before beginning activities • 4) The PEC must be wiped with a sporicidal agent at least monthly

• Radiation shielding equipment used in the classified room/SRPA or PEC that is exposed to patient care areas during the process of administration

• Must be cleaned and Disinfected before returning to any classified room (e.g., buffer or ante-room) or SRPA

• Centers for Disease Control and Prevention guidelines as non critical equipment requiring low-risk disinfection.

• Syringes that have been used in a patient care area MUST not be brought back into the classified room (e.g., buffer or ante-room) or SRPA for re-assaying or disposal.

129

6.6 Cleaning and Disinfecting Items from Patient Care Area

• Equipment that has been exposed to needles and syringes contaminated with blood-borne pathogens and RAMs are considered mixed waste

• (e.g., syringe shields and syringe carrying containers• This equipment must be cleaned and disinfected in procedures regulated

by the facilities’ RAMs license and application. • Equipment that contained mixed waste must be cleaned and disinfected

with an appropriate agent(s) for blood.

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6.6 Cleaning and Disinfecting Items from Patient Care Area

1. Surface Sporicidal Disinfectant agents tend to be:A. Strong OxidizersB. Quaternary AmmoniumsC. Phenolic agentsD. Alcohols (Isopropyl & Ethanol)

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2. In order to pass materials into the PEC, one must wipe materials with a nonlinting wipe saturated with:

A. Isopropyl Alcohol 70%B. Hydrogen Peroxide 6% or 3%C. Sterile solution that is a Non-residue DisinfectantD. Surface Sporicidal Disinfectant

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3. Daily Cleaning & Disinfection includes:A. PECs & Equipment inside PECs, Work surfaces outside the PECs, Floors, & Sink

(if applicable)B. Ceilings, Walls, & Storage AreasC. Hot Cells ( All Interior Surfaces, PECs & Equipment within a Hot CellD. Both A & C

133


4. Absorption of Cleaning & Disinfection Agents with subsequent radiation exposure might be limited by:

A. Sterile Chemotherapy SleevesB. Tyvek CoverallC. N95 maskD. Surgical mask

134


135

Questions?