6/23/2011. Compounded Sterile Products Update and Review. Learning Goals for the Pharmacist. Learning Goals for the Pharmacy Technician

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1 Compounded Sterile Products Update and Review Jo Ann Gibbs, PharmD Director of Pharmacy Byrd Regional Hospital Leesville, LA Learning Goals for the Pharmacist The pharmacist will be able to: 1. Identify areas for contamination of compounded sterile products during preparation. 2. Discuss responses to identified contamination of the compounding area. 3. Explain the proper technique for handling needle and syringe packaging to minimize the generation of particles. 4. Discuss the recordkeeping requirements that support the environmental management of the cleanroom and the glovebox. (Cleaning, temperature, pressures) 5. Discuss the annual educational requirements, including skills assessment and didactic testing. Learning Goals for the Pharmacy Technician The pharmacy technician will be able to: 1. Discuss work practices that decrease microbial contamination rates of compounded sterile products. 2. Identify risk areas for contamination of CSPs in everyday practice. 3. Discuss the proper technique for handling needle and syringe packaging to minimize the generation of particles. 1

2 Trends in Deficiencies Recordkeeping requirements: Records supporting the environmental management. Annual didactic testing. Annual skills assessment. Quality Assurance measures. Environmental & Quality Control Total Particle Counts Expectation ISO class 5-, 7-, and 8- classified areas and any of the primary engineering controls. All records shall be maintained and reviewed by the designated supervising employee. Frequency Every 6 months and whenever any alteration/relocation is done to the environment/equipment. 2

3 Pressure differential monitoring Expectation: Pressure from the ISO class 7 to pharmacy shall be >5Pa Airflow between buffer and ante area shall be a minimum velocity of 0.2m/sec. Frequency: Recorded every shift (minimum at least daily) or by a continuous recording device. Temperature and Humidity Monitoring Expectations: Provide a temperature and relative humidity sensor in each buffer room. Frequency: Continuous Monitoring Temperature < 68 F (20 C) Viable Air Sampling with Appropriate Growth Media Expectations Performed at locations prone to contamination. Volumetric Air Collection Frequency: Every 6 months as part of recertification of facilities/equipment. 3

4 Cleaning: ISO Class 5 Primary Engineering Control (LAFW, BSC, CAI, CACI) Expectations: Cleaning and disinfecting all areas before compounding begins. Using recommended disinfectants and materials. Frequency: At onset of each shift, before batches, after spills or surface contamination, and every 30 minutes during compounding activities Practice. Pharmacy Practice News April 2011: Counters/Works Surfaces/ Floors Expectations Appropriate cleaning and disinfecting agents. Frequency Daily Practice. Pharmacy Practice News April 2011:

5 Walls/Ceilings/Storage Shelving Expectations Appropriate cleaning and disinfecting agents Frequency Monthly Practice. Pharmacy Practice News April 2011: Why worry about air particulates: Particles in the can be introduced into the compounded product during preparation. The particulates themselves can cause issues (phlebitis). Bacteria, spores, and fungi can attach to particles and be introduced into the product during preparation. 5

6 Does 70% sterile Isopropyl Alcohol kill spores? 1. Yes 2. No 50% 50% 1 2 Tap water contains cfu/ml cfu/ml cfu/ml cfu/ml cfu/ml 25% 25% 25% 25% Recommended Cleaning Disinfectants and Materials Lint free wipes Sterile 80% Isopropyl Alcohol Does not kill Bacillus spores use bleach or other sporicidal agents on a schedule to avoid this. Sterile Water Drinking water can have anywhere between 500 and 1000 colony-forming units of microorganisms per ml. Weissfeld, Alice S., Vance, Paula H. Working with Microbiology to Eliminate Contamination of CSPs. Pharmacy Purchasing & Products 2011:Vol 8:No.5:2-6 6

7 Sterile Alcohol requires minutes of contact for proper microbicidal activity to take place minutes minutes 3. 0 min--works immediately! 4. Until it dries. 25% 25% 25% 25% nation_control How to Clean: Empty the trash containers. Vacuum the ceilings, floors and walls, in that order, with a HEPA-filtered vacuum. Use caution when cleaning HEPA filters; follow manufacturer recommendations. Clean and disinfect equipment such as laminar flow workbenches and other horizontal surfaces with nonshedding wipes. Use the top to bottom and back to front method using unidirectional motion with overlapping strokes. Use a pull-lift technique. Move from cleanest area to dirtiest area. (ie: Mop yourself out of the room) _Control 7

8 Does the method for opening syringe and needle packaging affect particle count in the LAFW or BSC? 1. Yes 50% 2. No 50% 1 2 How to open a syringe and needle: Peel and present generates the lowest number of particles. Pop-through the package is opened by pushing the device out of the packaging through the paper side of the web causing the paper to tear. Rapidly tearing strips of needles apart prior to opening generated excess particle counts. Rigid hard plastic packaging using the twist off method produced particles at a lower rate than paper packaging. Kastango, Eric S, et.al. Generation of particulate matter during handling of needle and syringe packaging. Am J Health-Sys Pharm. 2008:65:

9 Personnel Testing Initial training/demonstration: didactic training, written test, observational skill assessment, and media-fill testing Didactic training, written test, observations, media-fill testing: Observations of: Appropriate cleaning Garbing and handwashing Manipulation and placement of materials inside the compounding environment Allow alcohol to dry before proceding How to they open syringe and needle packaging Frequency: Prior to being allowed to prepare CSPs and during regular interval assessments. Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy Didactic Training ASHP video Quality Assurance for Pharmacy-Prepared Sterile Products. Valiteq video Aseptic Technique Validations System. Facility Managed program Needs to be well thought out and structured to include all aspects of cleaning and compounding. 9

10 Gloved Fingerprint Sampling Expectation: Sterile contact agar plates used to evaluate competency of hand-washing and garbing technique. Successful completion = Zero CFU Frequency: Complete 3 successful tests before compounding CSPs for human use Annually for low to medium risk CSPs Semiannually for high risk CSPs Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy Garbing and Gloving Competency Evaluation Expectation: Observe performing hand hygiene and garbing procedures. Jewelry removal Appropriate attire Cleanse hands/arms/elbows Frequency Regular visual observation to be documented, maintained, and assessed. At least annually Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy 10

11 Aseptic manipulation competency and media-fill testing Expectation Performed during media-fill test procedures that represent the most challenging/stressful conditions after successful completion of garbing and gloving competency. Maintain records of evaluation. Frequency Before compounding sterile products, then Annually (for low and medium risk CSPs) Semiannually (high-risk CSPs) Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy Cleaning and disinfecting competency evaluation Expectation Visual observation shall be documented and maintained for long-term assessment. Frequency Initial training on cleaning procedures Changes in staff Completion of any media-fill test procedure Surface cleaning and disinfecting Expectations Surface sampling performed in all ISO classified areas. Frequency Performed periodically (results as CFU/surface area unit) Set action levels and actions to be taken. 11

12 Action Levels ISO class 5 area (internal chamber) >3 CFU/ Plate What type of action? ICO class 8 area (anteroom or ante area) >100 CFU/plate What type of action? Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy Types of Actions Identify organism Evaluate effectiveness of cleaning agent. Search for source of contamination New construction? New staff? Do a thorough cleaning with appropriate cleaning agent and retest. 12

13 Viable air sampling is required at least: 1. Monthly 2. Quarterly 3. Every 6 months 33% 33% 33% The best method for viable air sampling is: 1. Passive sampling or gravity settling. 2. Volumetric or active air sampling. 3. One that involves swabbing the surfaces exposed to air. 33% 33% 33% Gloved fingertip sampling should be completed: 1. After the employee is gowned and gloved. 2. Before the employee washes his/her hands. 3. Is not needed if sterile gloves are used. 33% 33% 33%

14 Aseptic Manipulation Competency evaluation and media fill testing should be completed prior to compounding then: 1. annually or semiannually, depending on the type of compounding. 2. monthly thereafter. 3. quarterly thereafter. 25% 25% 25% 25% Competency Requirements must be documented in the following areas: Environmental Quality & Control Temperature & humidity Volumetric air and surface sampling Particulate counts and equipment certification Cleaning Daily and monthly logs Personnel Didactic training Gloved fingertip sampling Media fill testing Observational review competencies including Gowning & gloving Aseptic manipulation Surface cleaning and disinfecting References: United States Pharmacopial Convention, Inc. General chapter 797 pharmaceutical compounding sterile preparations is revised and finalized. (accessed Dec. 2007) Kastango, Eric S, et.al. Generation of particulate matter during handling of needle and syringe packaging. Am J Health-Sys Pharm. 2008:65: Weissfeld, Alice S., Vance, Paula H. Working with Microbiology to Eliminate Contamination of CSPs. Pharmacy Purchasing & Products 2011:Vol 8:No.5:2-6 Subramaniam, Vaiyapuri, et.al. USP <797> Monitoring Guidelines: Standards for Pharmacy Practice. Pharmacy Practice News April 2011:

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