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IV Sterile Compounding

Risks and Safety

1

Scarlett S. Eckert, Pharm. D.

Relevant Financial Relationships with Commercial Interests

Speaker’s disclosure of any relevant financial

relationships with any commercial interest.

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Objectives

Review the severity of IV compounding errors.

Review the New ‘proposed’ USP <797> requirements addressing IV compounding safety.

Review the USP <800> personnel, environment and patient safety requirements.

Describe the components of IV compounding errors.

Identify which risk factors and safety issues can be mitigated.

Discuss how to mitigate risk factors and improve safety of your cleanroom practices and compounded sterile products.

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Pre-Test Questions

1. With 100% IV compounding best practice in place 100% of the time, what would be the best accuracy percent you could expect?

A. 100

B. 80

C. 99.9

D. 75

2. The primary contributing factor of IV compounding errors can be contributed to:

A. Consumable labeling, vials and bags

B. Detailed and difficult to follow SOPs

C. USP <797> lack of regulatory guidance

D. Compounding staff and checking staff

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Pre-Test Questions

3. USP <797> proposed revision does not require visual inspection of

Category 1 CSP?

True or False

4. USP <800>, allow for Assessment of Risk for compounding drugs on

NIOSH table 1, 2 and 3.

True or False

5. It is possible to eliminate 100% of the risk associated with manual

compounding?

True or False

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Sterile Compounding Safety and Risk

What is “Safety”?

Condition of being protected from hazards, risks, and

harm

What is “Sterile Compounding”

Performing manipulations of presumed sterile

ingredients in a manner which prevents introduction

of viable and nonviable contaminants

(Proper nomenclature = Aseptic Compounding)

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What is in the bag?

Sterile compounding is the least transparent and most technique-critical process in the pharmacy: Start with sterile drug vial, diluent bags, needles, syringes

Accurately manipulate into needed dose and dosage form

Without introducing particulate or viable contaminant

Two potential safety risks that must be mitigated:

Accuracy of dose – must have confidence that every fluid transfer was performed within acceptable tolerance

Sterility of finished dose – must have flawless aseptic technique 100% of the time

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Sterility Assurance – The Invisible Problem

How do we assure sterility ?

Impossible to achieve 100% sterility using aseptic compounding techniques. Even with terminal sterilization, the practical sterility assurance limit is 1x10-6

With best practices used 100% of the time, the residual risk is 1:1000 for a contaminated dose.

For each contact of the sterile item with a non-sterile object, risk of contamination rises at least 30-fold (contamination recovery rate range 3 - 67%)

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Contaminated Doses Rate with

99.9% Sterility Rate

ANNUALIZED POTENTIALLY CONTAMINATED DOSES

WHEN STERILITY RATE 99.9%

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DOSES PER BED PER DAY

BED SIZE 1 2 3 4 5

100 37 73 110 146 183

200 73 146 219 292 365

300 110 219 329 438 548

400 146 292 438 584 730

500 183 365 548 730 913

600 219 438 657 876 1095

700 256 511 767 1022 1278

800 292 584 876 1168 1460

900 329 657 986 1314 1643

1000 365 730 1095 1460 1825

QUESTION 1

What are two (2) potential CSP safety risks that must be mitigated:

A. Accuracy of dose

B. Sterility of finished dose

C. Timeliness of compounding

D. Repetitive Motion Injury

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QUESTION 1 Answer

What are (2) two potential CSP safety risks that must be mitigated:

A. Accuracy of dose

B. Sterility of finished dose

C. Timeliness of compounding

D. Repetitive Motion Injury

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The Pew Charitable Trusts

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Pew’s drug safety project has identified more than 71 reported compounding

errors or potential errors associated with 1,416 adverse events, including 115

deaths, from 2001 to 2017. However, a 2015 survey found that only 30 percent of

states (13 or the 43 that responded) require sterile compounding pharmacies to

report serious adverse events. Of the states that require reporting, they type of

information that is required to be reported may vary, further contributing to an

incomplete picture of adverse events associated with compounded

medications. Even in states with strong adverse event reporting requirements,

illnesses and deaths caused by compounded drugs are not always linked to the

compounding error. Because many such events may go unreported, this chart is

likely an underestimation of the number of compounding errors since 2001,

Contamination of sterile products was the most common error, others were the

result of pharmacist and technicians miscalculation and mistakes in filling

prescriptions.

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Under reported Errors

WHY under reported? Lack of recognition

Seeing adverse events and errors as just part of the routine

Fear of retribution

You have to feel safe to report someone else’s error, or your own.

“Most hospitals have yet to create a safety culture.”

A sense of disbelief

“I remember talking to a hospital CEO once right after the report,” Gibson recalls. “He said that after a significant error, he would get up in the morning and look in the mirror and think, ‘Did this really happen here?’ There’s almost a sense that if you don’t see it, it didn’t exist.”

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The Hospitalist. 2012 July;2012(7)

Under reported Errors

Competing pressures

“The requirements of healthcare reform have taken up so much

time and energy that I fear safety has moved to the back burner”

“Someone in a quality and safety leadership role at one hospital

said to me, ‘Safety was just a fad. We’re not doing that

anymore.’”

Productivity demands

“Healthcare’s mantra today has become volume, volume,

volume. If you already have an environment that’s not as safe as

we would like, and you ramp up the volume so people have to

do more in the name of productivity, what’s going to happen?”

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The Hospitalist. 2012 July;2012(7)

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U.S. Illnesses and Deaths Associated With

Compounded Medications or Repackaged Medications

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U.S. Illnesses and Deaths Associated With

U.S. Illnesses and Deaths Associated With Compounded Medications or Repackaged Medications

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U.S. Illnesses and Deaths Associated With Compounded Medications or Repackaged Medications

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U.S. Illnesses and Deaths Associated With

Compounded Medications or Repackaged Medications

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U.S. Illnesses and Deaths Associated With

Compounded Medications or Repackaged Medications 19

U.S. Illnesses and Deaths Associated With

Compounded Medications or Repackaged Medications

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Studies and Statistics

Flynn, Pearson, Barker (1997)

9% mean error rate and 2% clinically significant

Essentially 1 out of every 10 sterile preps are flawed

Still quoted to this day by Institute for Safe Medication Practices (ISMP)

Moniz, Chu, Tom, et al (2014)

Study of over 425,000 compounded doses

6.8 errors per 1,000 doses - 23% undetectable by inspection

167 of the errors (0.04%) had potential for moderate or severe harm 4/10,000 of all doses compounded

Hingl, Deng, Lin (2015)

6 errors per 1,000 doses

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Studies and Statistics

Poppe, Savage, Eckel (2014)

13% of doses outside acceptable variance (+/-

10%)

Reece, Lozano, Roux et al (2016)

7% of doses had error in process

74% would not have been detected by

visual inspection

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United States Pharmacopeia (USP)

A scientific nonprofit organization that sets standards for the identity, strength,

quality, and purity of medicines, food ingredients, and dietary supplements

manufactured, distributed and consumed worldwide. USP’s drug standards are

enforceable in the United States by the Food and Drug Administration, and

these standards are used in more than 140 countries.

USP <797>:Pharmaceutical Compounding—Sterile Preparations

(under revision)

http://www.usp.org/compounding/general-chapter-797

USP <800>:Hazardous Drugs—Handling in Healthcare Settings

http://www.usp.org/sites/default/files/usp/document/our-

work/healthcare-quality-safety/general-chapter-800.pdf

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USP CHAPTER RELEASE DATES

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USP <797>

USP <797>

Guidelines for handling all CSP, personnel, training, compounding, environment, quality assurance and monitoring.

Represent the minimum requirements to be applied in compounding sterile preparations; however, it is always possible to exceed these standards.

Major Point:

Specific processes for Microbial control.

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Proposed USP <797>, Changes

Risk Categories:

Low, Medium, High 2 categories

Cleanroom design

Primary Engineering Control (PEC) classification

Sink location options

Environmental monitoring frequency

Personnel monitoring frequency

Personnel Protective Equipment (PPE)

Beyond Use Date

Sterility Testing samples requirement

Action Level for Personnel and Environment samples

In-Use time: addition of compounded source containers

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Proposed USP <797>: RISK Categories

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Proposed USP <797>: Cleanroom Design

All HEPA filtered airflow must come from the ceiling with

HEPA filter at the ceiling.

ACPH is based on number of personnel, particulates generated by

activity, equipment located in area, pressure and effects of

temperature.

Minimum ACPH: ISO 7= 30,

ISO 8 = 20,

non-HD SCA= no requirement

HD SCA= 12

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Proposed USP <797>: Cleanroom Design

Anteroom

Sink can be inside or outside classified area/ anteroom

No floor drain in anteroom

No water source or drain can be in buffer area

ACPH >/= 20 required ISO 8, >/= 30 required ISO 7

Garbing PPE order and location set by facility

ISO 8 or better, positive pressure for access to only non-hazardous

buffer area

ISO 7 or better, positive pressure for access to hazardous area

Or shared anteroom between non-HD and HD buffer areas.

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Proposed USP <797>: PEC Classification

PEC

Type

Device

Type

Placement for

Category 1

CSPs

Placement for Category 2 CSPs

LAFS LAFW Unclassified

SCA

ISO 7 positive pressure buffer with ISO

8 positive pressure ante-room

IVLFZ N/A ISO 7 positive pressure buffer with ISO

8 positive pressure ante-room

BSC Unclassified

SCA or C-SCA

ISO 7 positive pressure buffer with ISO

8 positive pressure ante-room

ISO 7 negative pressure buffer with

ISO 7 positive pressure ante-room

RABS CAI or

CACI

Unclassified

SCA or C-SCA

CAI: ISO 7 positive pressure buffer

with ISO 8 positive pressure ante-room

CACI: ISO 7 negative buffer/ ISO 7

positive anteroom

Isolator Isolator Unclassified

SCA or C-SCA

ISO 8 or better positive pressure room

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Proposed USP <797>: PPE Minimum Requirements 31

GOWNS: May NOT be saved for use later, non-hazardous or

hazardous

Proposed USP <797>: Personnel Qualifications

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Category 1 CSPs Category 2 CSPs

Personnel Qualifications

Visual Observation of

hand hygiene and

garbing

Every 6 months Every 6 months

Gloved fingertip

sampling (GFS)

Every 6 months Every 6 months

Media fill testing Every 6 months Every 6 months

Requalification Every 12 months Every 12 months

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Proposed USP <797>:

Environmental, Building and Facilities

Category 1 CSPs Category 2 CSPs

Building and Facilities

Primary engineering

control (PEC)

Not required to be

placed in a classified

area

Required to be placed

in a classified area

Recertification Every 6 months Every 6 months

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Category 1 CSPs Category 2 CSPs

Environmental Monitoring

Nonviable airborne

monitoring

Every 6 months Every 6 months

Viable airborne

monitoring

Every 6 months Every 6 months

Surface sampling Monthly Monthly

Proposed USP <797>:

Release Testing and BUD Assignment

Category 1 CSPs Category 2 CSPs

Physical

inspection

Required Required

Sterility testing Not Required Based on

assigned BUD

Endotoxin testing Not Required Required if

prepared from

non-sterile

ingredient(s)

BUD

BUD assignment </= 12 hours at

controlled room

temperature or

</=24 hours if

refrigerated

> 12 hours at

controlled room

temperature or

>24 hours if

refrigerated

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Proposed USP <797>: PEC Cleaning Clarification

Disinfect all interior surfaces of the PEC at the beginning and end of each shift, after spills, and when surface contamination is known or suspected.

Disinfect the horizontal work surface at least every 30 minutes while compounding if the compounding process takes 30 minutes or less.

If compounding takes more than 30 minutes do NOT disrupt the process, and disinfect PEC work surface once compounding completed.

Once daily:

1. Remove particles, debris or residue with appropriate solution (SWFI or SWFIr)

2. Clean with disinfectant detergent, mind the dwell time

At least Monthly, use a sporicidal detergent

3. Final sanitize with STERILE 70% IPA

Subsequent work surface cleaning: STERILE 70% IPA

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Proposed USP <797>: BUD Category 1 CSPs

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Immediate use: Must be administered within 1 hour of

first puncture of compounding process.

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Proposed USP <797>: BUD Category 2 CSPs Preparation Characteristics Storage Conditions

Sterilization

Method

Sterility

Testing

Performed

and Passed

Controlled

Room

Temperature

(20° – 25° )

Refrigerator

(2° – 8° )

Freezer

(-25° to -10° )

Aseptically

prepared

CSPs

No Prepared from

one or more

nonsterile

starting

components:

1 day

Prepared

from one or

more

nonsterile

starting

components:

4 day

Prepared from

one or more

nonsterile

starting

components:

45 day

Prepared from

only STERILE

components:

4 days

Prepared

from only

STERILE

components:

9 days

Prepared from

only STERILE

components:

45 days

Yes 30 days 45 days 60 days

Terminally No 14 days 28 days 45 days

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Proposed USP <797>: Sterility Testing

The BUDs specified in the table indicate the days after the Category 2 CSP is prepared

beyond which the CSP cannot be used. The BUD is determined from the time the CSP is

compounded. One day is equivalent to 24 hours.

The integrity of the container–closure system with the particular CSP in it must have been

demonstrated for length of frozen storage. The container–closure integrity test needs to be

conducted only once one ach formulation in the particular container–closure system in

which it will be stored or released/dispensed.

Multi-dose CSP formulation must pass antimicrobial effectiveness testing in accordance

with <51> at the time of preparation. The compounder may rely on 1. AET conducted or

contracted for, or 2. AER results published in peer-reviewed literature sources if the CSP

formulation (including any preservative) and container-closure system are exactly the

same as those tested.

The test must be completed and the results obtained on the specific formulation before

any of the CSP is dispensed. The test needs to be conducted only once on each

formulation in the particular container–closure system in which it will be stored or

released/dispensed.

Multi-dose CSP formulation must pass antimicrobial effectiveness testing in accordance

with <51> at the completion of sterility test (i.e., 14 -28 days after preparation per category

and type of organism testing for). The test must be completed and the results obtained on

the specific formulation before any of the CSP is dispensed. The test needs to be

conducted only once on each formulation in the particular container–closure system in

which it will be stored or released/dispensed.

38 Sterility testing follows USP <71> Table 2 and Table 3 for minimum quantity tested of each

medium. Exception if the batch quantity is between 1 – 39, USP 797 allows for 10% rounded

to the next whole number. Example 1 CSP requires 1 additional for testing, 39 CSP requires

4 additional for testing.

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Proposed USP <797>: IN-Use time

Manufacturer’s vials/containers:

Single Dose/Use = 6 hours once punctured

Removed within ISO 5 to allow for refrigerated item storage

Multi-dose = 28 days or per manufacturer if less

In-house compounded source containers:

Single Dose/Use = 6 hours once punctured for draws

Removed within ISO 5 to allow for refrigerated item storage

Multi-dose = 28 days or less depended on drug stability

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QUESTION 2

Which of the following statement is False per the proposed revision of USP <797>?

A. GFS and Media Fill testing increased to every 6 months

B. Training of compounding personnel must be completed annually

C. Surface sampling is specified to be completed at a minimum monthly

D. Visual inspection is not required for Category 1 CSPs

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QUESTION 2 Answer

Which of the following statement is False per the proposed revision of USP <797>?

A. GFS and Media Fill testing increased to every 6 months

B. Training of compounding personnel must be completed annually

C. Surface sampling is specified to be completed at a minimum monthly

D. Visual inspection is not required for Category 1 CSPs

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USP <800>

USP <800> address activities with potential risk of HD exposure and

the PPE required for handling IV HD drugs in any healthcare

environment, by any and all personnel.

USP <800> sets guidelines for handling all types of HD, IV, oral,

and topical, throughout any and all healthcare settings.

Major Point:

Specific processes for containment of possible HD contamination

and mitigation of exposure risks.

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USP <800>

This chapter describes practice and quality standards for handling hazardous drugs to

promote patient safety, worker safety, and environmental protection for both sterile and

nonsterile products and preparations.

Includes, but is not limited to:

receipt,

storage,

compounding,

dispensing,

administration,

disposal.

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USP <800>

Applies to all healthcare personnel who handle HD preparations, and entities which

store, prepare, transport, or administer HDs, includes but not limited to:

pharmacists, pharmacy technicians,

nurses, home healthcare workers,

physicians, physician assistants,

veterinarians, veterinary technicians

Entities that handle HDs must incorporate these standards into their

occupational safety plan. At a minimum, include:

Engineering controls Competent personnel

Safe work practices Proper use of appropriate PPE

Policies for HD waste segregation and disposal

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USP <800>

Elements Required:

Personnel requirements, training and competency

Facilities layout

Environmental quality and control

PPE

Hazardous Communication

Receiving

Transport

Administering

Deactivation/decontamination, cleaning and disinfection

Spill control

Disposal

Quality Assurance: product, environment and personnel

Medical surveillance

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USP <800>: Assessment of Risk Elements 46

All NISOH listed drugs, and drugs with

similar risk components, must be

handled per USP <800> containment

requirements UNLESS:

An Assessment of Risk is completed for

Table 1 drugs in final dosage form, Table

2 and 3 drugs requiring manipulation

and in final dosage form.

https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

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USP <800>: Assessment of Risk Elements

Assessment of Risk must consider:

Drug

Dosage form

Risk of exposure

Situational risk

Packaging

Manipulation / compounding

Documentation of alternative containment strategies and / or work practices

Review, at minimum, annually (document annual review)

Process to review and add new drugs

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https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf

USP <800>: Risk Elements

Not all hazardous defined drugs pose a significant direct occupational exposure risk because of their dosage form:

Medications in final dispensing form: tablets and capsules

These products may pose a risk if the dosage form requires alteration.

Cutting

Crushing

Dissolving

Piercing or opening

Compounding

MIND THE DUST!

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USP <800>: HD Storage Requirements

Hazardous drugs that may be stored with other inventory:

Non-antineoplastic

Reproductive risk only

Final dosage form of any HD including antineoplastic NIOSH Table 1

Antineoplastic HD requiring manipulation other than counting and all HD APIs

MUST be stored:

Separate from non-HD products

Negative pressure room, externally vented

ACPH at least 12

Preventing personnel exposure and insure containment

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Sterile and non-sterile HDs may be stored together outside of buffer area of

cleanroom, but ONLY sterile HDs should be stored in a buffer room under

negative pressure.

Question 3

To implement alternative containment and protection strategies less

than the requirements in USP <800>, each facility must complete an

Assessment of Risk. The Assessment of RISK does not apply to

antineoplastic listed on NIOSH Table 1 requiring manipulation and/or

compounding other than re-packaging the final dosage form.

True False

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Question 3 Answer

To implement alternative containment and protection strategies less

than the requirements in USP <800>, each facility must complete an

Assessment of Risk. The Assessment of RISK does not apply to

antineoplastic listed on NIOSH Table 1 requiring manipulation and/or

compounding other than re-packaging the final dosage form.

True False

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RISK Likelihood

Dying from influenza:

Causing a car accident while using cell phone:

Being struck by lightning in lifetime:

Dying in a car accident:

Dying in a plane crash:

Contaminating a sterile dose during compounding:

Perfect March Madness bracket:

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RISK Likelihood

Causing a car accident while using cell phone: 1:75

Contaminating a sterile dose during compounding 1:1,000

Being struck by lightning in lifetime: 1:3,000

Dying in a car accident: 1:5,000

Dying from influenza 1:10,000

Dying in a plane crash: 1:11,000,000

Perfect March Madness bracket: 1:9,223,372,036,854,775,808

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Components of IV compounding Errors

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Components of IV compounding Errors

People are the problem.

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Components of IV compounding Errors

People are the problem.

• Cannot consistently yield repeatable results

• Prone to use the path of least resistance and find shortcuts

• Expensive to train and maintain competency

• Denial and Disbelief of reality – “we have no errors”

• Refusal to look for problems – fear of reprisal if they find some

• Highly effective viable particle generators

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People: Contamination generally comes from skin

flakes and oil, cosmetics and perfume, spittle,

clothing debris (lint, fibers, etc.), and hair. People are

a major sources of particles. People are the #1 cause

of bio and particle burden.

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Components of IV compounding Errors

How have we dealt with the problem?

• Scrub them down and encase in marginally

effective particle barriers

• Create complex and difficult to use SOP’s

• Double (or triple) checks

• Supervise to ensure following SOP’s

• Retrain, audit, punish, replace, promote

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Components of IV compounding Errors

The problem remains: People.

• Sustained high-performance is difficult to achieve

• Resistance to change and refusal to use revised SOP

• Increasing demands: Increasing opportunities for error

+ Increasing propensity to take shortcuts

+ Decreased attention to detail

= Increased risk of error slipping through

PEOPLE are our biggest safety risk in sterile compounding.

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Sterile Compounding Safety and Risk

Have we improved the process?

• Yes, if the processes are designed to adequately mitigate risk AND

people follow the processes as designed.

• It is still not perfect – Swiss Cheese Model

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Question 4

The primary contributing factor of IV compounding errors can be contributed to:

A. Consumable labeling, vials and bags

B. Detailed and difficult to follow SOPs

C. USP <797> lack of regulatory guidance

D. Compounding staff and checking staff

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Question 4 Answer

The primary contributing factor of IV compounding errors can be contributed to:

A. Consumable labeling, vials and bags

B. Detailed and difficult to follow SOPs

C. USP <797> lack of regulatory guidance

D. Compounding staff and checking staff

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Sterile Compounding Safety

and Risk

Where are the hazards and risks ?

What kinds of harm can occur ?

What can we eliminate (protect from)

?

What should we/ can we mitigate

(reduce likelihood) ?

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Likelihood

of Occurrence

Severity of Harm

Likelihood of Escaping Detection

RISK

Safety in Sterile Compounding

Risk Factors and Safety Issues

Potential harm from CSPs

• Infection (viable organisms and spores)

• Fever (endotoxin)

• Vascular damage (particulates)

• Systemic reactions (contaminants or degradants)

• Therapeutic Failure (subpotent)

• Toxicity (suprapotent)

• Drug Shortages – harm resulting from inadequate

or absence of treatment

Risk Factors and Safety Issues

From a risk perspective, we must assume an unmitigated

hazard that reaches the patient will cause some degree of

harm

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• Accuracy of consumables is assumed, but regulatory

standards allow as much as +/- 10% variance

Visual inspection detects only gross defects in finished

product and may not detect defects in the

intermediary compounding steps

Syringe pull-back check method demonstrates the

intended dose, not what is actually in the finished dose

Risk Factors and Safety Issues

Detection of hazards in CSPs is unlikely

Likelihood of detecting CSP problems

• Sterility, particulate, and endotoxin testing are rarely performed,

and when performed only demonstrate that the tested samples

meet the specification

• Media fill testing of staff demonstrates capability for compounding

without contamination, not whether it is followed 100% of time

(Observer effect)

Methods to reduce likelihood of occurrence

• Eliminate root cause

• Detect and stop hazards earlier in process

• Reduce exposure to hazard source

• Decrease complexity

• Decrease variability

Manual processes are notoriously uncontrollable and

reliably inconsistent

Design a controlled process and consistently execute

process in accordance with design

Risk Factors and Safety Issues

Likelihood of occurrence is the element of risk over which

we have the greatest level of control to target for mitigation

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Likelihood of Occurrence

Severity of Harm

Likelihood of Escaping Detection

RISK

Reduction in

likelihood of

occurrence directly

reduces risk

Safety in Sterile Compounding

Risk Factors and Safety Issues

Improve safety in CSP compounding

Methods to reduce likelihood of occurrence

Eliminate root cause

Detect and stop hazards earlier in process

Reduce exposure to hazard source

Decrease complexity

Decrease variability

The #1 method to reduce likelihood of an identified hazard occurring is…

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Improve safety in CSP compounding

Methods to reduce likelihood of occurrence

Eliminate root cause

Detect and stop hazards earlier in process

Reduce exposure to hazard source

Decrease complexity

Decrease variability

The #1 method to reduce likelihood of an identified hazard occurring is…

69 AUTOMATION

PPP article from ISMP 9/21/2018

70

ISMP recommends use of technology to augment the

manual process

PPP magazine September 2018

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Question 5

Which component of Risk is easiest to control or mitigate?

A. Severity of Harm caused by a contaminated CSP

B. Detecting which CSP has been contaminated

C. Reducing the likelihood of contamination occurring

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Question 5 Answer

Which component of Risk is easiest to control or mitigate?

A. Severity of Harm caused by a contaminated CSP

B. Detecting which CSP has been contaminated

C. Reducing the likelihood of contamination occurring

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IV Workflow Systems

Mitigates non-contamination errors

Consumable picked

Drug,

Diluent

Compounding process – step by step instructions

If system has gravimetric scale and required weighing

Dosing,

Concentration

Does NOT mitigate possible contamination

Still Manual Process

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Every related process should incorporate Safety by Design-Look beyond the hood

Automation addresses the inherent human flaws in manual compounding,

most of which are difficult or impossible to detect by inspection

The right automation uses each of the key strategies that reduce likelihood of occurrence for compounding hazards:

Eliminate root cause – lack of control over process

Detect and stop hazards earlier in process – real time checks

Reduce exposure to hazard source – human, environment

Reduces repetitive motion issues - human

Decrease complexity – load, press start

Decrease variability – machine repeatability and consistency

Improve Safety in CSP

Compounding

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IV Automation Requirements

WHAT TO LOOK FOR IN IV AUTOMATION

IV Automation safety features must include:

ISO-5 or better aseptic environment maintained throughout the compounding process.

Unidirectional airflow with first air passing over critical sites.

No compounding process is completed over top of other consumables or products.

Inventory is stored in an ISO-5 environment, separate from the compounding area.

Provide dose accuracy and production repeatability.

No share needles or use IV tubing to transfer reconstitution diluents, or drugs.

Automatically disinfect critical sites, vials stoppers and bag ports.

Sanitize beyond what human cleaning of critical sites with sterile 70% IPA

Correctly label and gravimetric verification of the final product.

Direct validation of the fluid transfers.

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IV Automation Requirements

WHAT TO LOOK FOR IN IV AUTOMATION

The automation should not introduce risks back in to the process :

Remove human interaction from the compounding process.

Consumables should be verified within the automation process.

Eliminate the reliance on manual checks and inspections to identify

errors.

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IV compounding robots 77

KIRO - Grisfol

RIVA - ARxIUM

IV Station - Omnicell WEINAS - Weibond

EQUASHIELD

IV Automation Requirements

Compounding process needs to fully automate:

No manual intervention in the compounding process.

Products prepared are to be in final form ready for patient

use.

• System needs to be as efficient and cost effective:

– Cost per dose, pay-back.

• System needs to do what it is supposed to do.

• System must be accurate and reliable.

• The installation and service must be excellent and reliable.

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Question 6

Which Key Features IV Automation should include:

A. Unidirectional airflow over critical sites within an ISO-5 or better aseptic environment maintained throughout the compounding process.

B. No compounding is completed over other consumables or products.

C. Removes human interaction/involvement from the compounding process.

D. Provides digital record and images for all compounded CSPs.

E. No use share needles or use of IV tubing during compounding.

F. Consumables are verified within the automation process.

G. System should automatically disinfect critical sites, vials stoppers and bag ports.

H. System directly validates the fluid transfers and gravimetrically verifies final CPS.

I. System correctly labels for dispensing and verifies the final product.

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Question 6 Answer

Which Key Features IV Automation should include:

A. Unidirectional airflow over critical sites within an ISO-5 or better aseptic environment maintained throughout the compounding process.

B. No compounding is completed over other consumables or products.

C. Removes human interaction/involvement from the compounding process.

D. Provides digital record and images for all compounded CSPs.

E. No use share needles or use of IV tubing during compounding.

F. Consumables are verified within the automation process.

G. System should automatically disinfect critical sites, vials stoppers and bag ports.

H. System directly validates the fluid transfers and gravimetrically verifies final CPS.

I. System correctly labels for dispensing and verifies the final product.

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