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Understanding USP Chapter <797> Engineering Control Certification Requirements and Environmental Sampling and Remediation StrategiesCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2015 Pharmacy Education Series

April 15, 2015Understanding USP Chapter <797> Engineering Control Certification g p g g

Requirements and Environmental Sampling and Remediation Strategies

Featured Speakers:

Eric S. Kastango, RPh, FASHP, MBA James T. WagnerPresident PresidentClinical IQ, LLC and CriticalPoint, LLC Controlled Environment Consulting

1

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April 15, 2015Understanding USP Chapter <797> Engineering Control Certification

Requirements and Environmental Sampling and Remediation Strategies

Featured Speakers:

Eric S. Kastango, RPh, FASHP, MBA James T. WagnerPresident PresidentClinical IQ LLC and CriticalPoint LLC Controlled Environment Consulting

5

It is the policy of ProCE, Inc. to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Mr. Wagner has no relevant commercial and/or financial relationships to disclose. Mr. Kastango has no relevant commercial and/or financial relationships to disclose.

Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature.

Clinical IQ, LLC and CriticalPoint, LLC Controlled Environment Consulting

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist & Technician CE)

– 2.0 contact hours

Funding:This activity is self‐funded through CHSPSC

6

This activity is self funded through CHSPSC.



Understanding USP Chapter <797> Engineering Control Certification g g

Requirements and Environmental Sampling and Remediation Strategies.

Presented by James T. Wagner

President‐Controlled Environment Consulting dand

Eric S. Kastango, MBA, RPh, FASHP

President‐Clinical IQ, LLC

Learning Objectives

• Define the term “state of control” and the use of the term in relation to the certification report for primary and secondary engineering controls (Ph i d T h i i )(Pharmacist and Technician)

• Identify and differentiate between the various tests performed during certification of primary and secondary engineering controls (HEPA filter leak test; particle counts, room segregation, airflow velocity and smoke pattern testing) (Pharmacist and Technician)

• Describe the elements that must be understood in reading a certification report for isolators and other primary and secondary engineering controls (Pharmacist and Technician)

• Explain the importance of Environmental Sampling (Pharmacist and Technician))

• Discuss the elements of environmental and personnel sampling (Pharmacist and Technician)

• Outline a model ongoing environmental monitoring program, including the identification of baseline and action limits of microbial growth detected during environmental monitoring processes and remediation strategies (Pharmacist and Technician)

8



Background ‐ References

• NIOSH Alert ‐ www.cdc.gov/niosh

Preventing Occupational Exposure to Antineoplastic and other HazardousPreventing Occupational Exposure to Antineoplastic and other Hazardous Drugs in Health Care Settings

• United States Pharmacopeia ‐ www.usp.org

Chapter <797> Pharmaceutical Compounding‐Sterile Preparations (current version USP 37/NF 32)

• Controlled Environment Testing Association (CETA)

www cetainternational orgwww.cetainternational.org

• CAG‐001‐2005: Applications Guide for the use of Compounding Isolators in Compounding Sterile Preparations in Healthcare Facilities

• CAG‐002‐2006: Isolator Testing Guide

• CAG‐003‐2006: CETA Certification Guide for Sterile Compounding Facilities

9

Engineering Controls

•Engineering controls that are used in sterile compounding use airflow through High Efficiency Particulate Air (HEPA) filters to create air of the desired Cleanliness Classification:

• ISO Class 5 (direct compounding area inside of a primary engineering control such as a CAI)

• ISO Class 7 (buffer area or ante area adjacent to negativeISO Class 7 (buffer area or ante area adjacent to negative pressure ISO Class 7 hazardous buffer area)

• ISO Class 8 (ante area adjacent to non hazardous buffer area)

10



Primary Engineering Controls (PECs)

Laminar Air Flow Workbench(LAFW)

Biological Safety Cabinet (BSC)

11Refer to CHS Policy 22‐33‐P

Primary Engineering Controls (PECs)

Compounding Aseptic Isolator (CAI)

Compounding Aseptic Containment Isolator (CACI)




CAI Design Characteristics

Prerequisite Features of CAIs• Supplied with minimum type C or J HEPA filtered air

• May discharge unfiltered air into the room

• Note the following about CACIs:

• May discharge HEPA filtered air to the room only in the absenceof volatile HDs

• When used with volatile HDs then CACI air must be discharged• When used with volatile HDs, then CACI air must be discharged through a HEPA to outside the building

• Must maintain containment during compounding operations and material transfer


CAI Design Characteristics(continued)

Prerequisite Features of CAIs

• Must maintain ISO Class 5 during dynamic operating conditions

• Must be designed to allow for safe and effective disinfection

• Access to the CSP is through gloves

I d h h l d (RTP)• Ingress and egress through closed (RTP) or open systems (PTs) that protect the work area from the outside environment




Definitions: Isolator (2004 NIOSH Alert)

• A device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be y ( ) yreproducibly decontaminated.

• When closed, an isolator uses only decontaminated interfaces (when necessary) or rapid transfer ports (RTPs) for material transfer.

• When open, it allows for the ingress/egress of materials through defined openings that have been designed and validated to preclude the transfer of contaminants or unfiltered air to adjacent p jenvironment.

• An isolator can be used for aseptic processing, for containment of potent compounds, or for simultaneous asepsis and containment.

• Some isolator designs allow operations within the isolator to be conducted through attached rubber gloves without compromising asepsis and/or containment.

15

NIOSH Definitions

• Aseptic isolator: l d l d d l d l• A ventilated isolator designed to exclude external contamination

from entering the critical zone inside the isolator.

• Containment isolator: • A ventilated isolator designed to prevent the toxic materials processed inside it from escaping to the surrounding environment.

• Aseptic containment isolator: • A ventilated isolator designed to meet the requirements of both an aseptic isolator and a containment isolator.

16



Compounding Aseptic Isolator (CAI)

• A form of isolator specifically designed for compoundingdesigned for compoundingpharmaceutical ingredients or preparations.

• It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes.

• Air exchange into the isolator• Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbial retentive filter (HEPA minimum).


Compounding Aseptic Containment Isolator(CACI)

• A CACI designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. p p




Compounding Aseptic Containment Isolator

• Air exchange with the surrounding environment should not occur unless the air is first passed through a microbialair is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded.

• Where volatile drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly d i d b ildi il idesigned building ventilation.

• Unlike BSCs, there is no current NSF equivalent


Current USP Chapter <797> Position

“CAIs must be placed in an ISO class 7 buffer area UNLESS

they meet all of the following conditions:

1. The isolator shall provide isolation from the room and maintain ISO Class

5 during dynamic operating conditions, including transferring ingredients,

components, and devices into and out of the isolator and during

preparation of CSPs.

2. Particle counts sampled approximately 6 to 12 inches upstream of the

critical exposure site shall maintain ISO Class 5 levels during

compounding operations.

3. Not more than 3,520 ppcm shall be counted during material transfer,

with the particle counter probe located as near to the transfer door as

possible without obstructing the transfer.

(Sample procedures are detailed in CETA Applications Guide CAG‐002‐2006 section 2.09)

It is incumbent on the compounding personnel to obtain documentation from the manufacturer that the CAI will meet this standard when located in worse than ISO Class 7 environments. 20



Current USP Chapter <797> Position

• Recovery time shall be documented and internal procedures developed to ensure adequate recovery time is allowed.

• After transferring material into and out of the isolator• Before and during compounding operations

• Follow certification procedures such as those outlined in: • CAG‐003‐2006 shall be performed by a qualified individual no less than every 6 months

• CAG‐003 refers to CAG‐002 for isolator test procedures

If the PEC is a CAI or CACI that does notmeet the requirements above or is a LAFW or BSC not located in an ISO Class 7 area,

then only low risk, 12 hour beyond use dating (BUD) preparations can be prepared inside.

21

Gowning

• Compounding personnel are expected to wear the same b h i i l t d ib d f lgarb when using an isolator as described for a cleanroom

operation unless the manufacturer provides written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing is not required.

• Some manufacturers recommend hair net, gown and gloves when loading the ante chamber

• Consideration must be given to touch contamination and particulate transfer during the material loading process.

22



Glove Systems

• Manipulations within a barrier isolator are conducted

through a glove/sleeve (gauntlet) assembly.

• Two types of glove/sleeve assemblies are available:

• One‐Part: Glove and sleeve are single, unbroken unit

• Two‐Part:

• Glove and sleeve are separate and are connected at the

sleeve (gauntlet) by some type of seal system.

• The two‐part system allows for the relatively simple

change‐out of gloves.

• Most of the isolator systems sold to the US market are

provided with a two‐part assembly. 23

Glove Systems(continued)

• It is common practice to use a double

glove system to minimize the possibilityglove system to minimize the possibility

of a tear or leak to compromise the

environment within the isolator.

• An ordinary latex glove can be worn

underneath if desired.

• Don sterile gloves over the tops of the g p

isolator glove. Re‐sanitize the sterile

gloves frequently during compounding.

• Glove life will be affected by the cleaning

agents, solvents, and process materials.

An example of a “push-through” easy change glove system by

Innovative Technology, Inc. that is user friendly.

24



Glove Systems(continued)

• Gloves and gauntlets should be inspected daily for pinholes

as well as breaches at seams, gaskets and seals. as well as breaches at seams, gaskets and seals.

• A regular replacement program should be established so

gloves are replaced before a breach of integrity occurs.

25

A word about garbing and isolators…

26



Let’s discuss certification

27

Facility Engineering Control Certification

•Certifier Qualification• NSF Accreditation• CNBT Accreditation

•Certification reference material

• Controlled Environment Testing Association (CETA)( )

• www.cetainternational.org

Do not allow certification personnel into your controlled environments without completing hand hygiene and garbing!

28Refer to CHS Policies 22‐03‐P, 22‐33‐P



Primary Engineering Control Certification

•CETA CAG‐003‐2006

•NSF std. 49 – 2007

• LAFW: ISO 14644‐1

• IEST RP CC 002

• IEST RP CC 034

• Compounding Aseptic Isolators (CAI)

• CETA CAG‐002‐006

• ISO 14644‐1


Secondary Engineering Certification• CAG‐003‐2006: CETA Certification Guide for Sterile Compounding Facilities

• Airflow testing

• Room airflow

• Room segregation

• Airflow smoke pattern test

• HEPA Filter Installation Leak Test

• Particle Count Survey

• Optional tests

• Light, sound, temperature, humidity




Dynamic Tests

•Dynamic Tests (Room Objectives) require interaction between the certifier and the compounding staff

• Airflow smoke pattern test

• Particle Count SurveyParticle Count Survey

31

Certification Documentation Must Include:

•General information• Model, Serial number

• Location• Venting criteria

• To room, to roof, exhaust fan, type of damper, BMS, other hoods on same system?

• Type of cabinet• Name of certifier

• Print and sign

Reference: CETA CAG‐008‐2010

32



Certification Documentation Must Include: (continued)

• Test equipment used for each testf• Manufacturer

• Model and Serial number

• Calibration date and calibration due date

• Brief description of each test• This can be provided on a referenced SOP• Refer to any appropriate industry standards

• Acceptance criteria for each testAcceptance criteria for each test

• Pass/Fail statement for each test and for the unit overall• Refer to any appropriate industry standards

Reference: CETA CAG‐008‐2010

33

Isolator Certification

• CAIs used for sterile compounding should be certified every 6 months to the procedures outlined in CETA CAG‐002‐2006.

34



Certification Quick Reference CardSecondary Engineering Controls

Test Non Haz Buffer Anteroom HD Buffer

Airflow30 ACPH (at least 15 ACPH from outside the room)

Not specified but 20 ACPH is desirable

30 ACPH; 12 ACPH if CACI is used

Minimum differential pressure of 0.02” w.c. + Minimum differential pressure Minimum differential pressure

RoomSegregation

pressure of 0.02 w.c. +from cleanroom to

anteroom and all adjacent spaces

Minimum differential pressure of 0.02” w.c. + from anteroom to

all adjacent spaces

Minimum differential pressure of 0.01” w.c. ‐ from the HD cleanroom to the anteroom.

If displacement airflow, then velocity of 40 feet/minute from cleanroom to the anteroom across the entire opening

Not allowed in HD compounding

HEPA Filter Leak Test

All HEPA filters in the secondary engineering controls are tested at each certification. Maximum allowable leakage is 0.01% of the upstream aerosol concentration.

Smoke Pattern Testing

Buffer rooms must be segregated from the ante‐area and all other adjacent spaces. With the doors closed , use smoke around the opening of doors to ensure air is traveling in the right direction.Testing closed , use smoke around the opening of doors to ensure air is traveling in the right direction.

Non‐Viable Particle Counts

ISO Class 7ISO Class 8 unless it serves HD

buffer then ISO Class 7ISO Class 7

Airborne particle counter used to sample particle levels in all locationsunder dynamic operating conditions.

Temperature No specific requirement other than comfortable typically a temperature of 64°F

Humidity Not a mandatory test but Relative Humidity between 35% and 60% is recommended

Adapted from CETA Certification Matrix for Sterile Compounding Facilities CAG‐008‐2010 and reviewed by Jim Wagner in March 2014.Used with permissionCopyright © 2013‐2014 CriticalPoint’s Sterile Compounding Boot Camp™ ‐ All rights reserved

35

Certification Quick Reference Card

Traditional Primary Engineering Controls

TEST LAFWBSC

(NSF International Criteria)

Placement of Primary Engineering Control

Placed in ISO Class 7 cleanroom; 0.02” w.c. positive w.c. or SCA

Placed in ISO Class 7 Cleanroom,0.01”w.c. negative to anteroom

Airflow Velocity Velocity 80 to 100 feet/minute 6‐12” from the filter

Down flow Velocity Profile and Face Velocity Tests

HEPA Filter Leak TestHEPA filters must be certified to be free from leaks > 0.01% of upstream

aerosol concentration

HEPA filters must be certified to be free from leaks > 0.01% of upstream aerosol concentration or aerosol penetration not > 0.005% of upstream concentration for

filters that cannot be scanned

Airflow patterns smoke test

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air is undisturbed by compounding processes. Specific smoke pattern tests to ensure the device is functioning properly is also performed under “at rest” conditions.

Adapted from CETA Certification Guide for Sterile Compounding Facilities. CAG‐003‐2006‐11 and NSF/ANSI 49‐2012 and reviewed by Jim Wagner in March 2014.

Site InstallationAssessment Tests

N/A

Verifies that the BSC is properly integrated into the facility testing airflow and sash alarms; interlocks and exhaust system performance

Non‐Viable Particle Counts Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions under dynamic operating conditions

Used with permissionCopyright © 2013‐2014 CriticalPoint’s Sterile Compounding Boot Camp™ ‐ All rights reserved 36



Certification Quick Reference CardIsolator Type Engineering Controls

Test CAI CACI

Placement of PEC Preferably room/area devoted to compounding

Room certified to have at least 12 ACPH and be 0.01” w.c. negative to adjacent

room

Airflow Velocity Measurement of actual airflow to manufacturer’s design intent. The main chamber is Airflow Velocity gexpressed as a range of feet/min with a designated % uniformity.

Chamber Pressure TestDetermines that pass‐through and main chamber pressures adequate to provide isolator separation between main chamber and ambient spaces. Pressure range

determined by manufacturer.

Site InstallationAssessment Tests

Tests to verify proper alarm function; pass‐through door interlock function; and proper canopy or exhaust connection performance.

HEPA Filter IntegrityLeak Test

All HEPA filters in the secondary engineering controls are tested at each certification.

Maximum allowable leakage is 0.01% of the upstream aerosol concentration.

Airflow Smoke PatternTest

An observation using smoke to visualize airflow under dynamic operating conditions (with pharmacy staff compounding) to confirm laminarity of the air is undisturbed

Adapted from CETA Compounding Isolator Testing Guide. CAG‐002‐2006 and reviewed by Jim Wagner in March 2014.

Test (with pharmacy staff compounding) to confirm laminarity of the air is undisturbed

Preparation Ingress and Egress Test

Determine if the pass‐through system is capable of supporting material transfer while maintaining ISO Class 5 conditions during the transfer.

Non‐Viable Particle Counts

Particle counters capable of detecting 0.5 μm size particles are used to verify ISO Class 5 air conditions both at rest and during dynamic operating conditions.

Used with permissionCopyright © 2013‐2014 CriticalPoint’s Sterile Compounding Boot Camp™ ‐ All rights reserved

37

Exercise

• Review Sample certification report

38



Summary

The certification process should be more than just a “sticker” to get you through a regulatory inspection.

The certification process should be interactive to assure the facility will provide adequate support to your critical operation.

Many certifiers are being asked to do more than they have in the past. It should be verified that they can handle their new responsibilities.

39

Environmental Sampling and Remediation Strategies

40Refer to CHS Policies 22‐15‐P, 22‐30‐P, 22‐31‐P



Sampling and Monitoring ‐ Isolators

Cleaning of Isolator and Segregated Compounding Area

AND

All environmental sampling

(particle counts and viable air sampling)

AND

Personnel/work practice monitoring (surface and gloved fingertip sampling, aseptic media fills)

are required

regardless of primary engineering control used!

(LAFW, CAI and CACI)


Decontamination/Disinfection

• Transfer of material into and out of the isolator is one of the greatest potential sources of contamination. Routes include bags, boxes, paper and markers.

• Research has shown that:• 60% of consumables are contaminated with bacteria

• 40% of consumables are contaminated with bacterial spores

• Spraying alone is not enough:

Organism Spray Spray + Wipe

Aspergillus Niger 84% 98.5%

Bacillus subtilis 27% 94%

M. G. Cockcroft, D. Hepworth, J. C. Rhodes, P. Addison, A. M. Beaney. “Validation of Liquid Transfer Disinfection Techniques for Transfer of Components Into Hospital Pharmacy Cleanrooms,” Hospital Pharmacist (September, 2001). 42Refer to CHS Policy 22‐25‐P



Contaminated Material

Table 1: Sample testing of items routinely used in isolators

Item % contaminated % Bacillus (spores)

Syringe package 60.0 40.0

Swab package 66.7 16.6

Needle package 60.0 20.0

Sharps bin 57.1 42.9

M. G. Cockcroft, D. Hepworth, J. C. Rhodes, P. Addison, A. M. Beaney. “Validation of Liquid Transfer Disinfection Techniques for Transfer of Components Into Hospital Pharmacy Cleanrooms,” Hospital Pharmacist (September, 2001).

43

Decontamination / Disinfection

• The isolator design should facilitate physical disinfection of all work surfaces Interior seams should besurfaces. Interior seams should be shaped and sized to facilitate easy cleaning.

• All interior surfaces should be easily reached through the gloves to accommodate cleaning.

• If the interior is designed in a manner that does not permit easy physical disinfection of all surfaces, an alternative gaseous decontamination process must be developed and validated.




Decontamination / Disinfection

• Most isolators are difficult to disinfect because of thedisinfect because of the limitations of working through gloves.

• Many aftermarket products are available to make this task easier.

• Time should be factored into the process to allow forinto the process to allow for adequate daily disinfection as well as work surface disinfection between processes.

www.labsafety.com


Solutions Used in Daily Cleaning All Surfaces in PECs

• Non Hazardous LAFW/CAI • Hazardous: BSC/CACI

• Cleaning agent• Germicidal detergent: many of these are both cleaning and disinfecting agents; they have surfactants to remove macro contaminants

• Sporicidal agent (weekly/monthly)

• Deactivation/Decontamination• 2% sodium hypochlorite

• PeridoxRTU®

• Surface Safe (but sodium thiosulfate not required if deactivation is followed by cleaning)

• Cleaning agent• Disinfection

• Sterile 70% IPA (sIPA) all surfaces

Cleaning agent• Germicidal detergent

• Sporicidal (weekly/monthly?)

• Disinfection with sIPA




Gowning

• Compounding personnel are expected to wear the same

garb when using an isolator as described for a cleanroom

operation unless the manufacturer provides written

documentation based on validated environmental testing

that any component(s) of PPE or personnel cleansing is not

required.

S f d h i d l h l di• Some manufacturers recommend hair net, gown and gloves when loading

the ante chamber

• Consideration must be given to touch contamination and

particulate transfer during the material loading process.


Environmental Sampling

•Designed to demonstrate that the primary and secondary engineering controls, disinfecting y g g , gprocedures, and work practices result in a suitable environment for aseptic compounding

•Utilizes several approaches to assess and evaluate:• Total particle counts• Air viable organism cfu• Surface viable organism cfu• Surface viable organism cfu• Finger touch plates

Monitors State of Control




Widespread Expert Input

• Chapter ties viable and nonviable testing to certainnonviable testing to certain conditions as a minimumstandard for compliance.

• This approach was in response to the recommendations made by the Infection Control Advisory Panel, which had members from the CDC, APIC, SHEA, ASM, and a hospital based pharmacist.¹

¹ Arjun Srinivasan, Judene Bartley, William Rutala, Alice Weissfeld, and Kathleen Gura. Keith St. John was Chair of this Advisory Panel, appointed by CEO of USP, Roger Williams, MD

49

Two Categories of Environmental Sampling

Facility‐related

• Viable air sampling • Volumetric method (impaction)

Personnel‐related

• Personnel gloved fingertip sampling (GFS)

• at least every 6 months

• linked with re‐certification activities

• Initial is related to hand hygiene and garbing competency

• Ongoing is associated with media fill testing

• Surface sampling• for viable microorganisms

• Effectiveness of cleaning and disinfection (another employee related work practice)

50Refer to CHS Policies 22‐28‐P, 22‐29‐P, 22‐30‐P, 22‐31‐P



Is ES required in a Segregated Compounding Area?

• The chapter requires ES in the segregated compounding area.

• SCA contains only 1 ISO classified space

• Viable Air Sampling: still performed q 6 months when PEC is recertifiedViable Air Sampling: still performed q 6 months when PEC is recertified

• Surface sampling

• In association with Media Fill Units

• Randomly

• Gloved Fingertip Sampling

• Initially x 3 inside of the CAI if that is the PEC used

• Initially x 3 after hand hygiene and garbing in the space

• Ongoing in association with MFUs

• Randomly


Viable Air Sampling (continued)

• Shall be performed at locations that are prone to t i ti d i di t i f licontamination during compounding or staging of supplies,

labeling, gowning and cleaning.

• Think about the location of your CAI!

• Required frequency: AT LEAST semi‐annually

• More frequent sampling will provide earlier detection of loss of environmental control.

• Base frequency of sampling on:

• Nature of compounding occurring in the area

• Number of excursions over assigned action level




General Environmental Sampling “Shalls”• Detailed written PnP on all aspects of environmental sampling

• Sampling occurs in all ISO areas from cleanest to dirtiest ISO 5 ISO 7 ISO 8 SCA

• CFU Action Levels established

• Evidence of logical plan of action in the event sampling exceeds Action Levels

Classification

Volumetric

Air Sample

Required*

Table 2 in Chapter <797>

CFU/m3 air/plate(1000 liters) If < 1000 liters air sampled, convert to equivalent AL (e.g., 400 liter sample in ISO Class 7 then AL = >4 CFU/plate)

Required

ISO Class 5 > 1

ISO Class 7 > 10

ISO Class 8 > 100

SCA ?

Used with permission, © 2014, Clinical IQ, LLC. 53

Viable Air Sampling “Shalls”

• Viable air sampling performed:• at time of initial certification of PECs/SECat time of initial certification of PECs/SEC

• every 6 months in association with physical plant recertification

• after major service or device relocation

• Air sampling performed with volumetric sampler (not settling plates or paddles)

• Air sampling volume at each location is 400 to 1000 liters

• General growth medium and fungal specific medium

• Evidence that if Action Level is exceeded, area is cleaned and resampled

Used with permission. © 2014, Clinical IQ, LLC. 54



Volumetric Air Sampling Equipment

Merck MAS100

Biotest RCS Isolator

BioScience SAS180

Biotest RCS

SKC, Inc.

55

When to Perform ES?

In response to:• observed issues withobserved issues with compounding personnel work practices

• change in ES trend or finding• patient‐related infections where CSP is being considered as a potential source of the infection

• to monitor new situations that might effect environment (e.g., outsourcing of monthly cleaning to outside vendor)

56



What kind of Growth Media?

• Soybean Casein Digest Media (SCDM) or Trypticase Soy Broth/Agar (TSB/TSA) are generalBroth/Agar (TSB/TSA) are general growth media that support the growth of bacteria.

• Malt Extract Agar (MEA) or Sabouraud Dextrose agar (SDA) support the growth of fungi.

• Must use plates with lecithin and polysorbate 80 which are chemicals h l lthat neutralize cleaning agents when performing:

• Surface sampling

• Personnel glove sampling performed in association with MFU preparation

57

Environmental Sampling Media

Type of ESMedia Required by

USP <797>Best Practice

Recommendations

Viable Air Sampling General and fungal specific if high risk level compounder

General and fungal specific regardless of risk level

Surface Sampling General General and fungal specific

Gloved Fingertip Sampling: Initial

General General

Gloved Fingertip Sampling:Ongoing

General General and fungal

58Refer to CHS Policies 22‐30‐P, 22‐31‐P



Surface Sampling

• Important component of ensuring the maintenance of a it bl i bi ll t ll d i tsuitable microbially controlled environment

• Transfer of microbial contamination from improperly disinfected work surfaces via inadvertent touch contact by compounding personnel can be a potential source of contamination of CSPs

• Use for evaluating• facility and work surface cleaning and disinfecting procedures• employee competency in performing work practices

• USP Chapter <797> requires it to be performed• In all ISO classified spaces• “Periodically”


Surface Sampling (continued)

•Contact Platesdi l hi h h f• Media plate which has a convex surface

• General growth medium such as TSA with lecithin and polysorbate 80 which neutralize cleaning agents and prevent false negatives

• Only used to sample smooth, flat, and nonporous surfaces

• What size plate to use? A 50mm plate samples a surface area of 25 cm2area of 25 cm2

• How to use• Gently roll the plate over the surface to be sampled• Media residue will be left behind• Clean and disinfect sampled area thoroughly with sIPA




Gloved Fingertip Sampling (GFS)

•Required by the Chapter since the 2008 revision•Another personnel metric

• Initial and ongoing GFS•Must use media with lecithin and polysorbate 80 which will neutralize cleaning products


Initial GFS

• To verify that staff are able to don sterile glovesto don sterile gloves without contaminating them

• Part of the Hand Hygiene and Garbing Competency

• Sampled prior to disinfecting gloves with sIPA

• Passing is ZERO CFU both hands x 3 separate occasions




Ongoing GFS

•Occurs during media fill testing

• Required frequency:• Annually for facilities performing low and medium risk compounding

• Semi‐annually for high risk compounders

B t ti ti• Best practice tip:• Perform more often

• Randomly at end of day

• Associate with staff and with PEC

63

Incubation of Media

• TSB• Invert platesInvert plates

• Incubate plates at 30‐35°C • 48 to 72 hours

• MEA/SDA• Inversion not necessary• Incubate plates at 26‐30°C• 5‐7 days y

64



Environmental Sampling Action Levels

Classification

Volumetric

Air Sample

Required*

Gloved

Finger Tip

Sample

Surface Sample

Required Sample

ISO Class 5

ISO Class 7

ISO Class 8

> 1

> 10

>100

> 3

> 5

>100

Initial

ZERO

x 3

Ongoing

> 3

* CFUs per cubic meter of air per plate (cubic meter = 1000 liters) so if < 1000 liters of air sampled per plate must convert to 1000 liter equivalent (e.g., If 400 liters

What about the action levels for the Segregated Compounding Area?

p p p q ( g ,sampled in ISO Class 7, Action Level = >4 CFU/plate).

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Environmental Sampling Frequencies

EnvironmentalSampling Test

Required Frequency based on Chapter <797>

Suggested Best Practice Frequency

Non Viable Particle Counts • Initial facility commissioning • As requiredy g• Every 6 months during recert

of facility and engineering controls in compounding areas

q

Volumetric Air Sampling • Every 6 months • Weekly for high risk• Monthly for low/medium

GFS • Initially during garbing x 3• During Media Fills every 6

• Initially during garbing x 3• During media fills every week

months high risk• During Media Fill annually for

low medium

for high risk• During media fills monthly for

low/medium risk

Surface Sampling • “Periodic” • Weekly for high risk• Monthly for low/medium risk

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Actions to Take When Action Levels Exceeded

• An investigation into the source of the contamination must beof the contamination must be conducted.

• Sources:• High negative‐pressure in C‐SEC• HVAC systems: changes externally

• Damaged HEPA filters

• Changes in personnel garbing habitshabits

• Changes in work practices• Failure to follow PnP • New employees

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Excursions

•Analyze data• Compare to established levelsCompare to established levels.• Review types recovered.

• Investigate• Possible causes• Corrective action

•Resample• Control of facility returned.

•Document results, investigation and show successful remediation

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Speciation to Genus Level Currently Required“Regardless of the number of cfu identified in the pharmacy, further corrective actions will be dictated by the identification of micro‐organisms recovered (at least the genus level) by an appropriate credentialed laboratory of any microbialleast the genus level) by an appropriate credentialed laboratory of any microbial bioburden…”

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Occurrence Rate of Contamination

Cleanroom LocationGram +Bacteria

Gram –Bacteria

Fungi

Surfaces (wall, floor) High Low Moderate

Equipment/Instruments High Low/High Moderate

Air High Low Moderate

Water Low High Low

Personnel High Low Moderate

Materials brought in Variable

Adapted from Cleanroom Microbiology by T. Sandle and R Vijayakumar. PDA. DHI Publishing River Grove, Illinois. 2014 page 160.

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Bacteria and Fungi in Cleanroom Environments

Gram + Gram ‐ Fungi

Micrococcus

• luteus

Pseudomononas

• aeruginosa

Cladosporium spp.

Penicillium spp.• lylae

Staphylococcus

• epidermidis

• haemolyticus

• aureus

Bacillus spp. (spore forming)

Paenibacillus sp. (spore forming)

g

• moraxella

• oryzihabitans

• rhodococcus

Bacillus

• pumilus

• circulans

• megaterium

Penicillium spp.

Curvularia spp.

Aspergillus flagus

and many others…

p ( p g)

Corynebacterium spp. Pantoea spp.

Ralstonia picketti

Enterobacter cancerogenous

Aeromonas hydrophilia

Micobacterium spp.

Table represents information consolidated from Chapter 6, Cleanroom Microflora in Cleanroom Microbiology. 2014. 71

CFU Identification and Sources

Microorganisms Indication

Staphylococcus/ Micrococcus Personnel habits or gowning problemsStaphylococcus/ Micrococcus Personnel habits or gowning problems

Gram negative rods Water condensation, leaking, aerosols

Gram positive rods (bacillus spp.) Forms spores, Dust, dirt, floor traffic, possible air handling

Molds Influx of unfiltered air, mold from street clothing or mold‐contaminated cardboard, water reservoir, i.e. incubator humidification system

Yeast Possible outdoor air influx; clothing‐borne, especially in late summer/ fall; possible humanespecially in late summer/ fall; possible human contaminant

Diptheroids/ coryneforms Poor air conditioning (leading to sweating and personnel discharge from gowns)

Information compiled from Azzur Labs (www.azzurlabs.com) and Cleanroom Microbiology. Sandle T and Vijayakumar R. 2014

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Summary

• Understand that you need to know what your certifier is doing when he/she tests your engineering controlsdoing when he/she tests your engineering controls

• Understand your state pharmacy regulations as it relates to USP 797 and testing of your environment

• Require your certifier to test to the CETA testing guidance documents

• Review the results of the testing with the company

• Understand that environmental sampling (ES) is required when using any type of primary engineering controlg y yp p y g g

• Isolators are NOT exempt from ES (air, surface and GFS)

• Sterile gloves are required when using isolators

• Investigate, remediate and document any ES excursions

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Thank you

Our contact information:

James T. Wagner

[email protected]

Eric S. Kastango, MBA, RPh, FASHP

[email protected]

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Sterile Compounding Policies, Procedures, and Documentation to Meet USP Chapter <797> Standards

Jerry Reed, RPh, MS, FASCP, FASHPCHSPSC Pharmacy Services

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CSP Policy Overview

• 35 Policies• 35 Policies

• TJC references

• Contains procedures congruent with USP Chapter <797>

• Meet Federal regulations

• Contains additional competency documentation forms

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CSP Policy Sections

1 ‐ General

2 ‐ Quality Management

3 ‐ Inventory, Storage, and Handling

4 ‐ Compounding Facility Management

5 ‐ Training, Conduct, and Competency of

Compounding Personnel

6 ‐ General Compounding Processes

7 ‐ Hazardous Drug Compounding

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Section 1: General CSP Policies

Subject Policy Number

• General

• Administration

• Filters for IV Administration

• Infusion Control Device Use

• Priority Use of Infection Control Devices

• Standard Infusion Concentrations

• 22‐01‐P

• 22‐16‐P

• 22‐17‐P

• 22‐18‐P

• 22‐19‐P

• 22‐20‐P

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Section 2: Quality Management


St bilit d A i t f B d U D ti 22 09 P• Stability and Assignment of Beyond‐Use‐Dating

• End Product (Final Examination)

• Quality Management and Environmental Sampling Program

• Automated Compounding Devices

• Cleaning and Disinfecting of Compounding Area

• Aseptic Media Fill Testing and Process

• 22‐09‐P

• 22‐14‐P

• 22‐15‐P

• 22‐21‐P

• 22‐22‐P• Aseptic Media Fill Testing and Process Verification


• Sterile Compounding Viable Particle Testing

• Non‐Viable Particle Testing

• 22‐28‐P

• 22‐29‐P

• 22‐30‐P

• 22‐31‐P79

Policy 22‐15‐PQuality Management and Environmental Sampling Program

The quality management program for sterile compounding is designed to ensure that the compounding environment and personnel work practices will result inthat the compounding environment and personnel work practices will result in

a compounding environment with sufficiently low viable and non‐viable particles. Compounding staff must receive education related to principles of

compounding and trained on specific policies and procedures. Staff knowledge and performance must be verified through testing and competency evaluation. A comprehensive quality management program must include the creation of an Environmental Sampling Plan (ESP) in which the physical plant

and personnel practices are routinely monitored to ensure consistent performance. Data obtained through environmental monitoring ensures

objective evaluation and programmatic changes that will ensure and improve performance and quality.

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Personnel Related Metrics Facility Related SamplingPersonnel‐Related Metrics Facility‐Related Sampling


• Surface Sampling

• Personnel Media Fill Units

• Air Velocities

• Pressure Differentials

• Temperature

• Humidity

• Semi‐annual recertification

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Policy 22‐22‐P Cleaning and Disinfecting of the Compounding Area

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Policy 22‐22‐P Cleaning and Disinfecting of the Compounding Area

Cleaning Log

84



Policy 22‐30‐P Viable Particle Testing

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Section 3: Inventory, Storage, and Handling


• Inventory Storage and Handling

• Material Handling and Competency

• 22‐25‐P

• 22‐23‐P

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Section 4: Compounding Facility Management


• Sterile Compounding Facility Management

• Secondary Engineering Control Competencies

• Maintenance and Use of Isolators

• Preventative Maintenance and Certification of Environments and Equipment

• Temperature and Humidity Monitoring

• 22‐03‐P

• 22‐23‐P

• 22‐32‐P

• 22‐33‐P

• 22‐34‐P• Airflow Pressure Monitoring

• Primary Engineering Control Competencies• 22‐35‐P

• 22‐23‐P

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Section 5: Training, Conduct, and Competency of Compounding Personnel


• Orientation, Training, and Competency Evaluation of Pharmacy Personnel

• Hand Hygiene and Garbing Procedure

• 22‐23‐P

• 22‐24‐P

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Policy 22‐23‐P Orientation, Training, and Competency Evaluation of

Pharmacy Personnel

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Additional Competencies

Depending on the operations performed, the pharmacy may require the following additional competency assessments:following additional competency assessments:

• Material Handling

• Environmental monitoring

• BSC

• LAFW

• CAIs and/or CACIs

• Hazardous drug CSPs

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• Hazardous drug CSPs

• Automated compounding devices

• Sterility testing

• Pyrogen testing



Competency Assessment Documentation Forms

• Aseptic Technique

• Aseptic Technique for Immediate Use

• Cleaning and Disinfecting

• Primary Engineering Controls (BSCs)

• Primary Engineering Controls (CAI and CACI)

• Primary Engineering Controls (LAFW)

• Hand Hygiene and Garbing Competency

• Secondary Engineering Controls and Conduct in Controlled Environments

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Competency Assessment Documentation Forms

• Environmental Samplingp g

• Automated Compounding Devices

• Material Handling

• Filter Integrity Testing (Bubble Point)

• Pyrogen Testing (Gel Clot Method)

• Sterility Testing Membrane Filtration

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Policy 22‐24‐P Hand Hygiene and Garbing

• The purpose of this policy is to standardize the process by which all authorized personnel prepare to enter the controlled environments of the ante‐area andpersonnel prepare to enter the controlled environments of the ante area and buffer/cleanroom to further reduce sources of viable and non viable contamination.

• The greatest potential source of contamination of CSPs stems directly from the compounding personnel themselves. Vigorous hand hygiene and meticulous personnel garbing practices contribute to the significant reduction in particles thereby reducing the risk of CSP contamination.

• Human squamous cells are normally shed from the body at a rate of 1,000,000 h Th i l l d i h i bl i Thor more per hour. Those particles are laden with viable contaminates. The use

of cosmetics as well as the presence of rashes and infection increases the rate of shedding. Shed rates increase with the use of make‐up, rashes, and infection.

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Policy 22‐24‐P Hand Hygiene and Garbing

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Section 6: General Compounding Processes

• 22‐02‐P Sterile Compounding Procedures and Aseptic Technique

• 22‐05‐P Labels

• 22‐10‐P IV Piggyback Diluents

• 22‐11‐P Bulk Reconstitution

• 22‐13‐P Parenteral Nutrition

• 22‐26‐P Preparing Sterile Solutions from Non‐Sterile Components

22 2 di i Addi i l• 22‐27‐P Medication Additive Pools

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Section 7: Hazardous Materials/ Substances Policies

19‐01‐P General

19‐02‐P Preparation Areas

19‐03‐P Protective Apparel

19‐04‐P Receiving, Storage, Handling, Labeling, and Transport

19‐05‐P Preparing and Administering Drug using PhaSeal

19‐06‐P Preparing Non‐Parenteral Drugs

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Section 7: Hazardous Materials/ Substances Policies

19‐07‐P Administration

19‐08‐P Decontamination, Spill, and Waste Management

19‐09‐P Waste Disposal

19‐10‐P Safety Data Sheets

19‐11‐P Training and Safety

19‐12‐P Drug Compounding Techniques

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Hazardous Drug Compounding Competency Assessment Form

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Policy 19‐04‐PReceiving, Storage, Handling,

Labeling and Transport

This policy governs the general aspects of hazardous drug (HD) receiving, storage, handling, labeling, and transport that are not directly associated with compounding activities. For the purpose of this policy, HDs are those

substances that appear in Appendix A of the NIOSH Alert 2014‐138 as well as any updates as they become official.

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Policy 19‐04‐PReceiving, Storage, Handling,

Labeling and Transport Competency

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Policy 19‐05‐PClosed System Transfer Device ‐ PhaSeal

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102




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Hazardous Drug Risk Acknowledgement Form

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Did I Forget Something

105

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U d t C tU d t C t PhPhUpdate on Current Update on Current Pharmacy Pharmacy Initiatives and StrategiesInitiatives and Strategies

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Robert Fink, Pharm.D., M.B.A., FASHP, FACHE, BCNSP, BCPS

Chief Pharmacy Executive

Community Health Systems

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2015 Pharmacy - ProCEs3.proce.com/res/pdf/CHS/CHS2015AprHandout.pdf · CHS Pharmacy Education...

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