Personnel Training and Evaluation USP 797

Sterile Non-Hazardous Compounding <797>

Personnel Training and Evaluation
Sterile Non-Hazardous Compounding <797>

Purpose/ Applicability:  To ensure that all personnel who prepare CSPs are trained conscientiously and skillfully by expert personnel and meet the minimum requirements for being involved in the aseptic compounding process.

Scope: Training requirements are applicable to anyone preparing CSPs.

 

Definition(s):

USP : United States Pharmacopeia

CSP : Compounded Sterile Product

PPE : Personal Protective Equipment

ASHP : American Society of Health-System Pharmacists

Equipment:

ASHP Healthcare Video and Book

QI Medical Aseptic Media Fill Kit + Associated Materials

Chemoteq Aseptic Media Fill Kit + Associated Materials

Required PPE

Agar Plates for Fingertip Testing

Procedure:

Personnel Training:

  • Personnel who prepare CSPs must perform didactic review, pass a written examination and successfully complete media fill testing of aseptic manipulation
    • Written examination and didactic review must be completed annually
    • Media fill testing must be completed:
      • Annually if compounding low risk and medium risk preparations
      • Every 6 months if compounding high risk preparations
  • Any personnel who fail written tests or media fill tests should be immediately reinstructed and reevaluated to ensure correction of any deficiencies

Didactic Review

  • Complete by watching ASHP Healthcare Standards video and/or reading the associated textbook
  • Review how to properly garb and gown for both non-hazardous and hazardous rooms
  • Demonstrate ability to put on sterile gloves appropriately

Written Examination

  • Written examination developed based on the ASHP Healthcare Standards video and book
  • Must pass with at least an 80% 

Media Fill Testing

  • Complete per guidelines for non-hazardous and hazardous rooms – used to assess quality of aseptic skill of compounding personnel
  • QI Medical kit is used for aseptic non-hazardous and Chemo-TEQ kit is used for aseptic hazardous. Processes and procedures are below.

 

Certification Overview

  1. Watch ASHP Video Guide to Chapter <797> (60 minutes)
  2. Complete quiz and pass with 80% or higher
    1. Get quiz from Alex and return for grading
  3. Complete correct garbing procedure
    1. Follow procedure as attached
  4. Complete glove fingertip testing
    1. Following gowning procedure through to putting on sterile gloves then stop and complete testing
      1. Press fingertips of 4 fingers and then thumb against agar plate
        1. Repeat with other hand
      2. Make sure plates are labeled with name, L/R hand, and first gloved test
    2. Remove gloves and put on new pair
    3. While completing media fill process (after using alcohol and entering the hood)
      1. Press fingertips of 4 fingers and then thumb against agar plate
        1. Repeat with other hand
      2. Make sure plates are labeled with name, L/R hand, and second gloved test
  5. Complete media fill testing
    1. Follow instructions as attached
  6. Complete CHEMOTEQ certification
    1. Follow instructions as attached
  7. **Check glove fingerprint tests, media fill bags, and CHEMOTEQ bags after appropriate incubation periods to determine pass / fail 

 

 

Non-Hazardous Clean Room Certification Process

Supplies Needed:

 

Low/Medium Risk Preparation

4   Contact plates

1   GroMed ampule

  1. GroMed partially filled minibag
  1. GroMed 20 mL vial
  1. 3 mL syringe

1   Filter needle

21 18G x 1” needles

Alcohol swabs

 

 

 

High Risk Preparation

Nonsterile compounding room

  1. 3gm packet of soybean-casein digest broth
  1. 100 mL vial of sterile water
  1. 100 mL sterile vial
  1. 60 mL syringe

1   18G x 1” needle

 Alcohol swabs

 

Sterile compounding room

1   100 mL vial of dissolved soybean broth

  1. 0.2 microliter syringe filter

1    20 mL syringe

  1. 18G x 1” needle

Alcohol swabs

 

*Prior to going into clean room, the 3gm packet of soybean-casein digest broth must be dissolved in 100 mL of sterile water via heating and stirring. Dissolved broth can be brought into clean room in 100 mL sterile vial. (Can split up between vials if completing multiple tests)

 

Garbing Procedure, Fingertip Test, Cleaning Hood

Completed

Procedure

Comments

 

Remove jewelry / outerwear

 

 

Put on shoe covers / cleanroom shoes

 

 

Puts on appropriate mask

 

 

Puts on bouffant

 

 

Wash hands and forearms for at least 30 seconds

 

 

Dry hands with lint free wipes

 

 

Put on gown and boots

 

 

Disinfect hands with sterile alcohol

 

 

Put on sterile gloves appropriately (do not touch anything after putting gloves on)

 

Complete gloved fingerprint test #1

 

Completed

Procedure

Comments

 

Press fingertips of 4 fingers and thumb of left hand against agar plate

 

 

Repeat with right hand

 

 

Discard sterile gloves

 

 

Disinfect hands with sterile alcohol

 

 

Put on sterile gloves appropriately

 

Enter nonhazardous side of cleanroom

 

Completed

Procedure

Comments

 

Clean hood properly with sterile alcohol (top to bottom, back to front)

 

 

Clean IV pole properly with sterile alcohol

 

 

Spray each component prior to placing it in the hood

 

 

Spray gloves before entering the hood

 

 

If the hood is left for any reason, gloves need to be sprayed with alcohol before re-entering

 

 

 

Completion of Media Fill

Low/Medium Risk Preparation

Completed

Procedure

Comments

 

Grab components for both preparations, spray them with alcohol, and enter the hood

 

 

Ensure all products are at least 6 inches in the hood and all preparations are completed at least 6 inches in the hood

 

 

Wipe the vial, and all injection ports of the bag with alcohol

 

 

Using an 18G needles and 3 mL syringes, withdraw 1 mL from the vial and inject it into the bag

 

Complete gloved fingertip test #2

 

Press fingertips of 4 fingers and thumb of left hand against agar plate

 

 

Repeat with right hand

 

 

Discard sterile gloves

 

 

Disinfect hands with sterile alcohol

 

 

Put on sterile gloves appropriately

 

Finish low/medium risk preparation

 

Change the needle and repeat the process for each of the remaining 19 needles using the same syringe

 

 

Final transfer should empty contents of the vial

 

 

High Risk Preparation

Completed

Procedure

Comments

 

Followed all instructions as previously described on first page to prepare the soybean broth and transfer the contents into a 100 mL sterile vial for the preparation

 

 

Wipe down vial top and port of bag with alcohol swabs

 

 

Using an 18G needle and 20 mL syringe, draw out 10 mL of the nonsterile product

 

 

Remove the needle and attach a 0.2 microliter filter and new needle to the syringe

 

 

Inject 10 mL of the sterilized product into the bag from the low/medium risk preparation

 

 

Cleaning and De-garbing

Completed

Procedure

Comments

 

Dispose of syringes and sharps in the appropriate container

 

 

Throw away plastic and wrappers in trash can

 

 

Clean hood properly with sterile alcohol (top to bottom, back to front)

 

 

Clean IV pole properly with sterile alcohol

 

 

De-garb in the anteroom appropriately

 

 

 

Once out of the cleanroom – (For Pharmacist)

  • Label the final bag
  • Immediately inspect bag for particulates, coring, fibers
    • Nothing should be present in the bag and if it is then it should be recorded as to not be mistaken with microbial growth later on
  • Incubate at room temperature for 14 days
  • Examine daily for turbidity
    • If turbidity is observed, growth from microorganisms is indicated and the test is positive
    • If the bag is clear, the test is negative and the operator has passed the test

 

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________

 

 

Gloved fingertip test – (For Pharmacist)

  • Incubate at room temperature for 14 days
  • Examine daily for growth
    • If growth is observed, test is positive and operator has to redo portion that failed
    • If no growth observed, test is negative and operator has passed the test

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________

 

 

 

 

Hazardous Clean Room Certification Process

 

Hazardous Compounding Validation Testing Procedures with Equashield®

 

Video Training for First-Time Participants:

Before completing the media fill test for the first time, participants should watch the ASHP Compounding Sterile Products video (approximately 60 minutes) and complete the Cleanroom Certification Assessment (quiz).

 

Participants should also watch Equashield Training Video at http://www.equashield.com/how-to-use.

  • The following short videos will be the most helpful*
    • Withdrawing From a Vial
    • Preparing an IV Bag with Any Tubing
    • Reconstitution with a Diluent Vial
    • Syringe to Syringe Transfer

 

* It should be noted that while these Equashield videos demonstrate proper use of the Equashield closed-system they do not show the correct technique to use while working in a vertical flow BSC. Participants should be careful to always hold syringes, vials, and bags at angle so as not to obstruct airflow from above. It is also important to swab any adapter ports with alcohol that may be contaminated.

 

Each Media Fill Test requires the following supplies:

CHEMOTEQTM Validation Kit Supplies:

  • (1) Vial of red of 25 mL Chemoteq media
  • (1) Vial of red of 50 mL Chemoteq media
  • (1) Package of bag/bottle labels (for 1 vial, 1 syringe, 1 bag)

 

Equashield® Supplies:

  • (2) Spike Adapter 1T
  • (4) Vial adapters size 20
  • (3) 35 mL syringes
  • (1) 20 mL syringe
  • (3) 10 mL syringes
  • (3) 3 mL syringes
  • (1) Luer Lock Adapter LL-1DC (syringe to syringe connector)

Additional supplies required:

  • (1) 50mL bag normal saline
  • (1) 250 mL empty bag
  • (1) 10mL or larger empty sterile vial
  • (1) Administration tubing set
  • (1) Vial 50 ml sterile water for injection (SWFI)
  • (1) Vials 50 ml NS for injection

 

Garbing Procedures:

Date:________________________

Completed

Procedure

Comments

 

Remove jewelry / outerwear

 

 

Put on shoe covers / cleanroom shoes

 

 

Puts on appropriate mask (N95)

 

 

Puts on bouffant

 

 

Wash hands and forearms for at least 30 seconds

 

 

Dry hands with lint free wipes

 

 

Put on gown and boots

 

 

Put on second pair of boot covers

 

 

Put on goggles

 

 

Disinfect hands with sterile alcohol

 

 

Put on nonsterile chemotherapy gloves

 

 

Disinfect gloves with sterile alcohol

 

[Enter hazardous clean room]

 

Put on chemotherapy gown

 

 

Put on sterile gloves

 

 

Disinfect gloves with sterile alcohol

 

 

Validation procedure:

Completed

Procedure

Comments

 

Clean hood properly with sterile alcohol (top to bottom, back to front)

 

 

Open chemo mat in hood

 

 

Spray each component with alcohol prior to placing it in the hood

 

 

Spray gloves before entering the hood to begin your preparation

 

 

If hands leave the hood for any reason, the must be resprayed with alcohol prior to re-entering

 

 

Wipe down all ports with alcohol swabs ; wipe down any vial tops throughout process with alcohol swabs

 

 

Spike empty 250 mL bag with spike adaptor 1

 

 

Attach administration set to the 50 mL normal saline bag, prime the tubing, and clamp to prevent leakage (Spike adaptor 1 and tubing)

 

 

Put vial adaptor size 20 on NS vial and withdraw 50 mL then transfer to the 250 mL empty bag using equashield syringe (Use 35 mL syringe and transfer 25 mL at a time)

 

 

Put a vial adaptor size 20 on a VM-50 vial and transfer to the 250 mL empty bag using a new equashield syringe (Use 35 mL syringe and transfer 25 mL at a time)

 

 

Put vial adaptor size 20 on a 50 mL sterile water vial and another vial adaptor size 20 on a VM-25 vial. Withdraw 25 mL of sterile water (using new 35 mL equashield syringe) and inject into VM-25 vial.

 

 

Using 10 mL equashield syringes, draw up 7 mL into each of the 3 syringes from VM-25

 

 

Inject 2 of the syringes into 250 mL bag

 

 

Using 3 mL equashield syringes, draw up 1 mL into each of the 3 syringes from VM-25

 

 

Inject all 3 of the syringes into the 50 mL normal saline bag

 

 

Draw up 1 mL of sterile water into a 20 mL syringe

 

 

Using a LL-1 DC luer lock adaptor, connect the sterile water syringe to the 7 mL syringe filled with media

 

 

Transfer the media into the sterile water syringe then disconnect the syringes

 

 

Cap syringe with sterile vial cap

 

 

Label vial, bag, and syringe with date and operator’s initials. (Keep adapters on the vials.)

 

 

Collect bag, vials and syringe in Ziploc bag

[[Supervisor : monitor for growth for 2 weeks]]

 

Cleaning and De-garbing:

Completed

Procedure

Comments

 

Dispose of all syringes and vials in blue chemo bin

 

 

Dispose of all plastic, wrappers, and chemo mat in trash can

 

 

Clean hood with alcohol (top to bottom, back to front)

 

 

Remove sterile gloves, chemo gloves, and chemo gown in chemo room

 

 

De-garb in anteroom in reverse order

 

Once out of the cleanroom – (For Pharmacist)

  • Label the final bag
  • Immediately inspect bag for particulates, coring, fibers
    • Nothing should be present in the bag and if it is then it should be recorded as to not be mistaken with microbial growth later on
  • Incubate at room temperature for 14 days
  • Examine daily for turbidity
    • If turbidity is observed, growth from microorganisms is indicated and the test is positive
    • If the bag is clear, the test is negative and the operator has passed the test

 

 

Supervisor acknowledgement of no growth after 2 weeks:

 

Signature: _______________________________________    Date: ____________________

 



KeywordsTrain, Evaluation, Requirement, Skill   Doc ID130902
OwnerJenny C.GroupUofI College of Veterinary Medicine Teaching Hospital
Created2023-09-06 14:29:50Updated2023-09-07 14:37:07
SitesUniversity of Illinois College of Veterinary Medicine Teaching Hospital
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