Disclosure: OPERATION C.L.E.A.N. I do not have a vested interest … · 2018-08-08 · Aseptic Techniques: Sterile Cmpd Application of technique utilizing methods, manipulations,
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8/8/2018
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OPERATION C.L.E.A.N. OPERATION C.L.E.A.N. Compounding: Leveraging and Elevating Awareness in a New Era
Presented by:Audrey B. Johnson, BPharm, CPh, MSM
#FSHP2018
Disclosure: I do not have a vested interest in or affiliation with any corporate
organization offering financial support or grant monies for this continuing education activity, or any affiliation with an organization whose philosophy could potentially bias my presentation.
Objectives:Objectives:• Recognizing issues in sterile procedures and
compounding • Recognize trouble shooting and steps that need to be
taken to fix problems in both aseptic and extemporaneous compounding
• Explain the steps that need to be taken before and after aseptic and extemporaneous compounding
(referencing USP 795, 797, and 800)
#FSHP2018
What do you mean by “Clean”?What do you mean by “Clean”?
Compounding requires a host of Procedures, practices, and processesIncluding skills, techniques, documentation, testing, and most of all your “Integrity”!
How do we guard against what we cannot see?
#FSHP2018
The 2018 Florida Statutes
#FSHP2018
Florida Pharmacy Law64B16-27.797Adoption of USP Chapters
797 – Sterile Compounding71 – Sterility Tests85 – Bacterial Endotoxins
www.floridapharmacy.govFLORIDA DRUG AND COSMETIC ACTChapter 499.0121Storage and handling of prescription drugs; recordkeeping
USP Chapters United States Pharmacopeia
Provides guidance for safety, quality, and efficacy of products compounded for human consumption or use • USP 795 Provides guidance of compounding
utilizing Non-Sterile componentscompounded preparations for consumption/use
• UPS 797 Provides guidance for compounding utilizing Sterile products
• USP 800 Provides guidance for compounding Hazardous products both Sterile and Non-Sterile (hazard levels)
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Improvements in Compounding Compliance increased from 77% in 2011 to 87% in 2018
We still have improvement steps to make (+/- 20%)
“Prevent Contamination”
How? Follow the Guidelines (Policy & Procedure)
When? Always
Why? Product & Patient Safety
Deviation from process creates opportunities for Harm
Objective 1: Recognizing issues in sterile procedures and compounding
ASHP Time line of Events for Sterile compounding
Issues identified in Sterile Compounding:
www.CDC.gov
Event Trends from 1970 – 2012753 injured
64 Deaths in 753 injured….more reported /many unknown-and recent reporting's have been added –although delayed occurrences secondary exposure and residual injuries
Response: Federal & State levelsRapid and Aggressive changes in Regulations and Guidance standards for the Compounding of Medications
Changes in Agency oversightSeparation of ActivitiesRequirements of PerformanceStandards for PracticeFacility conformance General Requirements
2019 Release of New Guidelines for USP 797, 800, 795 and FDA (503A- 503B)
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The Impact of “Issues”…. 2012 event
#FSHP2018Time: 02:00
General causes of issues: • Inadequate Training• Inadequate Equipment• Deviation of process • Improper Cleaning• Failure to follow procedure• Improper Storage • Using beyond established time• Contaminations • Use of Out dated/Expired contents• Improper Storage & Stability data
• Beyond Use / dating• Inadequate gowning• Stretching Guidelines • Non-compliance• Personnel Activities• Poor Environmental Conditions• Compromised Air Quality• Inadequate Aseptic Technique
#FSHP2018
Example of an Exterior environment exposures
Example of Improper Gowning exposure:
Types of Contamination
Touch(aseptic
techniques)
Cross(technique-practice)
Exposure(personnel/product/air)
Viable Non-Viable
“Prevent Contamination”
How? Follow the Guidelines (Policy & Procedure)
When? Always
Why? Product & Patient Safety
Deviation from process creates opportunities for Harm
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How does contamination occur?
How do we trouble shoot?
What Measures should be taken?
#FSHP2018 #FSHP2018
Follow the Guiding Rules:
#FSHP2018
Objective 2:
Recognize trouble shooting and steps that need to be taken to fix problems in both aseptic and extemporaneous compounding
RCA & CAPA:
•What Happened?•Where Happened?
What was the impact?
(How many defects)
•What was the impact? •How many defects/errors?
Analyze:
•What was involved? •Who was involved?
•Establish correction which will prevent reoccurrence (aka: Action Plan)
Trouble shoot & Fix problems
RCA: Root Cause Analysis• Define/Identify the issue• Evaluate Magnitude/Impact• Identify Cause• Analyze and Document Cause
• Procedure/Process• Persons/People• Product ? –recalls, storage, shipping• Equipment • Environment• Microbiology test –growths/samples
CAPA: Corrective And Preventive Action• Correct the issue
• Identify the cause and corrective action needed
• Establish the Preventive action• Establish a redesign of the
process • Re-educate or Re-train• Service-Update- or Replace
systems/equipment
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Calibrations Validations
Training AssessmentMonitoring
Workflow design
Validate
Calculations Calibrations
Testings
EngineeringMonitoring
CertifyAir Quality
Viable-NonViable
CleaningExposure
Aseptic Processes AnalysisSterility
VerificationDocumentation
?What is all of this???
Activities of involvement for Safe compounding of pharmaceutical products for use:
Product
EnvironmentPEC/SEC
Air
EquipmentTested
Calibrated
Material & Supplies
Storage&
Stability
Quality
PersonnelTraining
The Elements for Controls in Safe Compounding:
Essential Areas for Compliance Practices: Personnel • Aseptic Training • Compounding Skills• PPE- Personnel Protective• Hand Hygiene
Environmental Controls• ISO Classifications • Air Quality
(Particles/Temperature/Pressure) • Cleaning
(supplies/solutions/frequency)
Engineering & Equipment: • Cleanroom Designs• Primary & Secondary• Hoods /BCA & BCC• Equipment –Supplies Cleaning
Quality Assurance: • Environmental Monitoring• Product Testing • Personnel –Process Validations
Personnel Training & Awareness: Required Training with Documentation:
Aseptic Technique Media Fill Validation-Touch Plate Proper Garbing & Gowning – Touch PlatesHand Hygiene Cleaning practices
Written Assessment & Observational are required
Annually or Semi-Annually for Hazardous or High Risk
#FSHP2018
Aseptic Techniques: Sterile Cmpd <797>
Application of technique utilizing methods, manipulations, and process to prevent the introduction of bacteria, virus or micro-organism contamination1st line of defense for safe preparation
Some steps in Aseptic practice include:• Hand washing and application of antimicrobial agent with persistent activity• Sterile IPA for swabbing and wiping • Proper use Sterile Gloves• Cleaning workspace, outer containers with Sterile IPA• Use new supplies with each unique compound/batch • Replace compromised items- gloves, needles, garb• Work 6 inches within the PEC (hood/box) • Do Not touch critical sites• Do Not block first air flow from hood
Common Cleanroom Micro-Organisms
• Micrococcus spp.• Staphylococcus spp.• Corynebacterium spp.• Bacillus spp.• Aspergillus spp.• Pencillin spp.
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Techniques : Non-sterile Extemporaneous <795>
• Apply techniques of Sterile- Hand Hygiene/Gloves/Gowning • Use Clean sanitized equipment and supplies• Prepare workspace with only necessary items • Do NOT share Compounding workspace• Clean workspace after each preparation • Label and store properly• Place used supplies in appropriate area• Ensure measures are correct• Equipment calibrated• Use cleaning units properly – sanitizing, sterilizations, incubation• BUD- expiration date factoring all components used*
Common Organisms: Extemporaneous
•
Cleanings & Solutions:
Anti-sporicidalBroad SpectrumQuintenary Bleach 2% measured accurately for concentration valueSterile IPA (not 70% Isopropyl basic) – Sterile with COAPeroxide Fungicidal
Room Design & Engineering:
• Room design- layout
• Segregated by Activity
• HVAC –designated with access
• HEPA Filters- High Efficiency Particle Air
• Temperature Monitoring
• Humidity Monitoring
• Ceiling Tiles - Lightings
• Walls/Floors
Engineering & Equipment:
Air Duct external exhaust
HEPA Filters
Work bench
Waste bins
Pharm Waste
Control Particles: Non-lint sheading wipes
Product Wipe down before entry
Air Quality Testing Minimize In/Out – Product Introduction – Misc.
Surface CleaningSterile IPA- Sterile Water
Cleaning requirementsDaily: Compounding Surface/Floors
Weekly: Daily + Cleaning Solution changeMonthly: Ceiling –Walls- Surface-Carts-Bins
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ISO Classifications (Air Quality)ISO Classifications (Air Quality)International Science Organization for Standardization
#FSHP2018
According To USP 797, What Levels of Viable Colony Counts Are Considered Elevated?
The following table lists the action levels adapted from the Pharmaceutical Compounding - Sterile Preparations <797>,
that when exceeded must initiate further investigation.
ISO Class
Active Airborne (cfu*/m3)
Glove Fingertip (cfu/contact plate)
Inanimate Surfaces** (cfu/contact plate)
5 > 1 > 3 > 3
7 > 10 not required > 5
8 > 100 not required > 100
Quality Assurance: Monitoring & Maintenance:
#FSHP2018
Pressure Monitoring: ACH –air changes per hour
Temperature Monitoring: below 70
Quality Assurance: Air –Surface-Product testing's Viable (micro organisms) & Non-Viable (particles)
Cleaning: Solutions and Microbial coverage required
Case Study: 2011: Multiple Patients Blinded Due to Avastin Contamination6
Patients in California, Florida, and Tennessee were blinded after receiving Avastin that had been contaminated during medium risk level compounding. Additionally, one patient suffered permanent brain damage.
How did the contamination occur? A. Process:
B. Product:
C. Environment:
D. Container/Supplies:
#FSHP2018
Techniques : Non-sterile Extemporaneous <795>
• Apply techniques of Sterile- Hand Hygiene/Gloves/Gowning • Use Clean sanitized equipment and supplies• Prepare workspace with only necessary items • Do NOT share Compounding workspace• Clean workspace after each preparation • Label and store properly• Place used supplies in appropriate area• Ensure measures are correct• Equipment calibrated• Use cleaning units properly – sanitizing, sterilizations, incubation• BUD- expiration date factoring all components used*
Steps to take Before & After Compounding:
Before: 1. Prepare in proper attire – follow Garbing – Gloving requirements2. Clean and Prepare the workspace 3. Review required materials – correct, intact, pure4. Review Date opened/ Use date/expiration date)5. Evaluate supplies for use- (do not use6. Review Compounding Procedure prior and review after completion 7. Aseptically prepare only 1 compounded product in a session*
After Completion: 1. Label Properly2. Conduct proper cleaning between sessions3. Reverify contents used- “as a post-compound review” 4. Package Properly 5. Clean work space with Sterile IPA 6. Change gowning/glove if necessary
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#FSHP2018
Tips for Success not provided in Guidance and Rules: • Train Properly – Assess Abilities • Evaluate compliance of personnel• Adequate Staff for Workload• Design Workflow processes • Review and Update processes• Allow proper time for compounding • Establish sound procedures• Avoid deviations from process • Conduct random evaluation • Inspect frequently (watch out for Shortcuts and Work arounds) • Provide adequate resources and supplies• Replace broken and defective equipment • Invest in a Compounding Documentation Software Program*
“Prevent Contamination”
How? Follow the Guidelines (Policy & Procedure)
When? Always
Why? Product & Patient Safety
Deviation from process creates opportunities for Harm
The Acronyms:The Acronyms:PEC: Primary Engineering ControlsSEC: Secondary Engineering controlsPPE: Personnel Protective Equipment BUD- Beyond Use Date API-Active Pharm. IngredientHEPA- High Efficiency Particle AirCFU’s- Colony Forming Units
PEC
SEC
PPE
BUDIPA
HEPA
CFU
#FSHP2018
References: • USP-NF Compendium ; Chapters 797, 795, Assessments• www.USP.org• Florida Pharmacy Law; 64B26.797 • ASHP Trends –trending; Journal April 2011• Pharmacy Products & Purchasing; April 2018• Pharmacy Today • Carter Health –catalog image• Florida Cleanroom – production image• Compounding Pharmacy Today• PDA Journal of Pharmaceutical Science & Technology; 2011
Operation C.L.E.A.N.Operation C.L.E.A.N.
Questions & Answers?
Thank you for your participation!
“Follow the Guidelines”
#FSHP2018
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