Sterile Products 2024 BPSA Lab Manual PDF

Sterile Products & USP Anna E. Shook, PharmD, BCPS, BCOP Assistant Professor of Pharmacy Practice Drake University College of Pharmacy PGY1 Residency Director Mary Greeley Medical Center PHAR 145: BPSA2 1 Pronouns: She/Her Office Hours: Wednesdays 1400-1600 Appointment preferred Virtual option Offic...

Sterile Products & USP Anna E. Shook, PharmD, BCPS, BCOP Assistant Professor of Pharmacy Practice Drake University College of Pharmacy PGY1 Residency Director Mary Greeley Medical Center PHAR 145: BPSA2 1 Pronouns: She/Her Office Hours: Wednesdays 1400-1600 Appointment preferred Virtual option Office Location: Cline 005 2 3 Semester Schedule March 18-19 Sterile Products Review, USP March 25-26 Parenteral Drug Administration & Sterile Compounding Practice, IV Lines and Compatibility April 1-2 Generic Drug Substitution (Dr. Mengesha) Sterile Compounding (in lab with Dr. Shook) April 8-9 Hazardous Drugs & USP April 15-16 Sterile Products Practical 4 Learning Objectives Identify and assess the importance of critical sites in sterile product compounding Establish appropriate aseptic technique, taking into consideration airflow direction, reconstitution of vials, and appropriate distance within the hood Determine the correct dosage and rate of compounded sterile products and prepare a label accordingly Describe the scope and components of USP Chapter 5 Sterile Products Lab Practical Format Assess dosage calculations and aseptic technique using the Sterile Products Rubric (posted in Blackboard) Five (5) minutes Calculations & Labeling Ten (10) minutes Compounding May complete/update calculations and labeling if needed Unlimited materials à May start over 6 Critical Sites Goal: Keep sterile materials sterile during manipulations Avoid touching critical sites Keep critical sites in “first air” Critical Sites Hub of needle Shaft of needle Hub of syringe Exposed syringe plunger Rubber stopper of vials Ports of IV bags 7 Appropriately Calculates Amount of Drug (7 Points) Correct Weight Correct Single Dose Total Volume 2.2 lbs = 1 kg mg/dose mL/dose Note any divided dosing Different for IV bags 8 9 Label Bag Correctly (10 Points) Patient Name: Drug Name: Concentration of Vial: (will be given to you) Dose: Time/Date Prepared: Time/Date of Expiration: (assume 24 hours unless told otherwise) Initials: Total Volume: Rate: Concentration in Bag: 10 Rate Rounding May round to nearest ml/hr IV bag mL/hr Each dose is to be given IV PUSH administered over 2 minutes IV push Syringe - push over X minutes Each dose is to be an IV piggyback infusion in X mL of fluid over X hours IM Each dose is to be an IM injection IM in syringe 11 Common Labeling Challenges Concentration in vial Drug in IV Bags Concentration of the vial is “per mL” Thus 10mg/10ml = 1mg/ml Add “in 50 ml NS” or “in 100mL NS” if IV admixture Total Volume In IV Bags Concentration in bag Total Volume + Bag (NS) N/A for IM or IV push products 12 13 Example Label #1 Order: Ceftriaxone 750 mg IM x 1 Patient Name: CM Drug Name: Ceftriaxone Concentration of Vial: 250 mg/mL Dose: 750 mg Time/Date Prepared: 3/6/23 @ 1300 Time/Date of Expiration: 3/7/23 @ 1300 Initials: AS Total Volume: 3 mL Rate: IM Concentration in Bag: NA 14 Example Label #2 Order: 900 mg Cefazolin in 50 mL NaCl 0.9% over 30 minutes Patient Name: WB Drug Name: Cefazolin (in 50 mL NS) Concentration of Vial: 330 mg/mL Dose: 900 mg Time/Date Prepared: 4/1/23 @ 0800 Time/Date of Expiration: 4/2/23 @ 0800 Initials: AS Total Volume: 52.7 mL 2.7 mL drug + 50 mL NS Rate: 105 mL/hr Concentration in Bag: 0.059 mg/mL 15 Correct Reconstitution of Drug (5 Points) Correct technique (swabbed) Toward you, 3 times is ASHP-recommended best practice Air added to diluent Pressurize vial Usually exchange ~2mL at a time for small vials Correct volume of diluent added Air withdrawn Shaken: gently swirl or roll Tips: Needle enters and exits vials on surface of hood If recapping needles, “inverted V” or “scoop” 16 Draw up Correct Amount of Drug (13 Points) Re-swab vial Air added Correct product added (IVPB, IVP, IM) Automatic failure if incorrect or miscalculated No sprays or loss of product in hood Use different entry point in stopper, pressurize 17 Aseptic Technique (15 Points) Work in Hood Critical Sites 6 inches from edge Correct manipulation of vials and syringes Do not touch any critical sites or block airflow access to critical sites Do not touch hub or plunger of syringe/needle Do not block airflow (pass over) Correctly space items in hood (2 finger-widths apart) 18 Common Challenges Vial Reconstituted Incorrectly Inappropriate final dose “Passing Over” Working directly above a critical point Air Bubbles Swabbing Vials Expel from syringe, don’t worry about the little ones Initial swab after cap removal, 3x TOWARD you, re-swab before re-entry 1x 6 inches in the hood Critical Site(s) Bringing syringe close to face to check volumes, throwing out garbage and syringe follows Airflow blocked to needle by “extra/unused” fingers Grabbed syringe plunger (not bottom circle) 19 20 Watch the Needle: Reconstitution Too low: solution regurgitates into syringe Too high: if needle bevel touches stopper, may leak diluent out top Above the liquid level 21 Watch the Needle: Drawing Dose Too high: pulling in air Too low: if needle bevel touches stopper, may leak Needle should be in fluid space so you are withdrawing liquid rather than air 22 Tips for Success Bubbles “Knock” when syringe upright Pull in extra air Large bubbles “swallow” small bubbles Leaking Vial Pull down on plunger Rescues solution from the leaking vial and lowers pressure 23 Avoiding Needle Sticks Maintain awareness Sharps container nearby Always place the sharp(s) directly into the sharps container when completed Replace sharps container when 75% full Utilize safety techniques when recapping the needle Swoop or Inverse V All needlestick accidents should be reported Respond according to protocol 24 25 The “Big Picture” Phase 1 Reconstitute vial per instructions Phase 2 Draw up enough resultant solution to prepare ONE dose Phase 3 IM/IVP -> STOP IV Bag -> inject into bag 26 USP United States Pharmacopoeia Set of enforceable compounding standards Sterile Compounding: USP Hazardous Drug Compounding: USP Nonsterile Compounding: USP 28 Categories of Compounded Sterile Preparations Category 1 Least controlled environmental conditions Room Temp (20-25°C) BUD 12 hours Refrigerated (2-8°C) BUD 24 hours Category 2 More environmental controls than Category 1 Category 3 Highest level of environmental controls 29 Immediate-Use CSPs Compounded for direct and immediate administration Not subject to the requirements for Category 1, 2, or 3 CSPs when all the following are met: Processes are in place to minimize contact with nonsterile surfaces, conventionally manufactured products, or CSPs Prepared according to drug labeling Preparation involves not more than 3 different sterile products Any unused starting component is discarded after preparation Administration begins within 4 hours from start of preparation Must be labeled with names and amounts of ingredients unless administration is performed by the person who prepared the compound 30 Hygiene Must wash hands and forearms up to the elbows with soap and water for at least 30 seconds Remove visible debris from under fingernails with disposable nail cleaner Brushes are not to be used Dry hands and forearms completely with low-lint disposable towels or wipes Hand dryers are not to be used 31 Garbing Requirements Low-lint gown with sleeves that fit snugly around wrists with an enclosed neck Low-lint shoe covers Low-lint head covering that covers all hair and ears Facial hair cover, if applicable Low-lint face mask Sterile powder-free gloves Sterile 70% isopropyl alcohol applied to gloves before entering the compounding area and regularly throughout compounding 32 ISO Classification ISO Class Particle Count per Cubic Meter 3 35.2 4 352 5 3,520 6 35,200 7 352,000 8 3,520,000 Sterile compounding facilities must minimize risk of airborne contamination of the compounding area Air quality standards: ISO 33 Air Quality Requirements Anteroom with access to positive-pressure buffer room ISO Class 8 20 ACPH Anteroom with access to negative-pressure buffer room ISO Class 7 30 ACPH Buffer room ISO Class 7 30 ACPH Preparation of Class 1, 2, 3 CSPs ISO Class 5 34 Cleaning Definitions Cleaning Agent Used for the removal of residues such as dirt, debris, residual drug from surfaces Disinfectant Used on surfaces and objects to destroy fungi, viruses, and bacteria Sporicidal Agent Destroys bacterial and fungal spores when used at a specific concentration for a specified contact time 35 Cleaning and Disinfecting Frequency Site Cleaning Disinfecting Sporicidal Agent PEC and Equipment within PEC Daily and when contaminated Daily and when contaminated Category 1/2: Monthly Apply 70% IPA at least every 30 minutes to work surface Pass-Through(s) Floor Daily Daily Walls and Doors Ceilings Storage Bins Monthly Monthly Category 3: Weekly Monthly 36 Pass-Through LAFW (PEC) 37 Introducing Items into the SEC and PEC Must wipe all items with Sterile 70% IPA using low-lint wipes while wearing gloves Critical sites must be wiped with Sterile 70% IPA before entry 38 Beyond-Use Dating: Category 2 CSPs Compounding Method Controlled Room Temp (20-25°C) Refrigerator (2-8°C) Freezer (-25 to -10°C) Aseptically Processed 30 days 45 days 60 days Terminally Sterilized with Sterility Testing 45 days 60 days 90 days Terminally Sterilized with No Sterility Testing 14 days 28 days 45 days 39 Beyond-Use Dating: Category 3 CSPs Compounding Method Controlled Room Temp (20-25°C) Refrigerator (2-8°C) Freezer (-25 to -10°C) Aseptically Processed with Sterility Testing 60 days 90 days 120 days Terminally Sterilized with Sterility Testing 90 days 120 days 180 days 40 Single- and Multi-Dose CSPs Single-Dose Vials If vial entered in ISO 5 or cleaner air, may be used up to 12 hours Ampuls may NOT be reused Multi-Dose Vials Designed to contain more than one dose and can be entered multiple times Typically contain a preservative to inhibit growth of microorganisms After initial entry, multi-dose vial BUD 28 days 41 42 Lab Preparation Please bring scratch paper and calculator Review demonstration video and example math/labeling video prior to lab Business casual or scrubs Closed-toe shoes 43