*Arizona Board of Pharmacy * Current Good Manufacturing Practices - CFR *Beyond-Use Date (BUD)

Transcription

1 Beyond-Use Date (BUD) The date or time after which a compounded sterile preparation (CSP) shall not be stored or transported. The date is determined from the date or time the preparation is compounded Southwestern Clinical Seminar March 7-9, 2014 Have Fun Review <797> Pharmaceutical Compounding Hand Sanitizer Math Review What is 797 about? Prevent harm to patient Outlines conditions and practices to reduce exposure to: Microbial contaminations Excessive bacterial endotoxins Variability in intended strength Unintended chemical & physical contaminants Quality of ingredients in compounding sterile preparations (CSP) As per the FDA Compounding does not include mixing, reconstituting, or similar acts that are preformed in accordance with the directions contained in approved labeling provided by the product s manufacturer and other manufacturer directions consistent with the labeling (e.g. amoxicillin 250mg/5ml suspension) Microbial Contamination Risk Levels Low-Risk Level CSP Medium-Risk Level CSP High-Risk Level CSP Arizona Board of Pharmacy Current Good Manufacturing Practices - CFR

2 Low-Risk Level CSP Compounded and aseptic manipulation entirely within ISO Class 5 or better air quality using only sterile ingredients, products, components and devices Only transfer, measuring & mixing NOT more than 3 commercially manufacture sterile products & NOT more than two entries into any one sterile container or package (eg bag, vial) Medium-Risk Level CSP Multiple individual or small does of sterile products are combined or pooled to prepare a CSP that will be administered either to multiple patients or to one patient on multiple occasions. Process includes complete aseptic manipulations other than the single-volume transfer Process requires unusually long duration, such as that required to complete dissolution or homogeneous mixing Low-Risk Level CSP cont Manipulations are limited to aseptically opening ampuls, penetrating disinfected stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration device, package containers of other sterile products and containers for storage and dispensing Medium-Risk Level CSP Proper storage before administration Exposed to controlled room temperature not more than 30 hours Not more than 9 days at cold temperature and for 45 days in solid frozen state between -25 degrees and -10 degrees Examples TPN manual or automated Filling reservoirs of injections and infusion devices with more than three sterile drug products and evacuations of air from those reservoirs before the filled devices is dispensed Transfer of volume from multiple ampuls or vials into one or more final sterile containers. Low-Risk Level CSP cont Proper storage before administration Exposed to controlled room temperature not more than 48 hours Not more than 14 days at cold temperature and for 45 days in solid frozen state between -25 degrees and -10 degrees Examples Single-volume transfers of sterile forms from ampuls (sterile filtered), bottles, bags and vials using sterile syringes with sterile needles, other administrations devices and other sterile containers. Simple aseptic measuring and transferring with not more than three packages of manufactured sterile products, including an infusion or diluent solution to compound drug admixtures and nutritional solutions High-Risk Level CSP Nonsterile ingredients, including manufactured products not intended for sterile routes of administration (e.g. oral) are incorporated or a nonsterile device is employed before terminal sterilization. Exposure to air quality worse than ISO Class 5 for more than 1 hour For example: Sterile contents of commercially manufactured products CSPs that lack effective antimicrobial preservatives Sterile surface of devices and containers for the preparation, transfer, sterilization and packaging of CSPs

3 High-Risk Level CSP Proper storage before administration Exposed to controlled room temperature not more than 24 hours Not more than 3 days at cold temperature and for 45 days in solid frozen state between -25 degrees and -10 degrees Examples Dissolving nonsterile bulk drug and nutrient powders to make solutions that will be terminally sterilized Exposing the sterile ingredients and components used to prepare and package CSPs to room air quality worse than ISO Class 5 for more than 1 hour Measuring and mixing sterile ingredients in nonsterile devices before sterilization is performed Assuming, without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated between uses Bacteriostatic Defined as - Agent that stops bacteria from reproducing Hand sanitizer works as Antiseptic Agents per CDC Antimicrobial spectrum and Characteristic of Hand-Hygiene Antiseptic Agents Source- MMWR Recommendations & Reports 10/25/2002 / 51(RR16);45 Risk Levels CSP ISO Class Transfer, measuring & mixing Low Class 5 ore than 2 entries into one product Medium Class 5 Multiple doses combined to admin multiple occasions High Class 5 Nonsterile ingredients, use of non sterile device Summary of Risk Levels Manipulation limits From ampuls, vials via syringes to admin device Multiple transfers Exposure to < class 5 > 1 hr Storage /BUD <48hrs room temp 14 day cold <30hrs room temp 3 day cold <24hrs room temp 3 day cold Alligations Using Alligations as A Math Technique Hand Sanitizer Review the steps Review Additives Demonstrations Using alligations to solve problems that involve diluting or concentrating liquids The Lab has 500ml bottle of % Isopropyl Alcohol in Carbomer Suspension. You have been asked to prepare a concentration of 66% (v/v) final volume 60ml. H2O is the diluent. How much of the % (v/v) Isopropyl Alcohol in & how much water is needed to make 66% (v/v) Isopropyl with a final volume of 60ml.

4 Use the following five steps: 1. Determine whether diluting or concentrating a liquid. a) If diluting, find the diluent. It s either 0% or some % lower than the wanted %. b) If concentrating, find the pure drug. It s either 100% or some % higher than the wanted %. 2. Determine Haves & Wants. 2. Determine Haves & Wants. The Lab has 500ml bottle of % Isopropyl Alcohol in. You have been asked to prepare a concentration of 66% (v/v) final volume 60ml. H20 is the diluent. How much of the % (v/v) Isopropyl Alcohol in & how much water is needed to make 66% (v/v) Isopropyl with a final volume of 60ml. Answer: Have - % Isopropyl Alcohol in & Water as diluent concentration 0%. Want: 66% (v/v) Isopropyl, final volume of 60ml. Continuation steps 3-5: 3. Set up grid system and fill in the values in the H (Haves) & W (Wants) columns. Perform diagonal subtractions. 4. Set Ratio Proportions using values from U/P/R (use, parts, ratio) column. 5. Calculate out the ratio proportions. 3. Set up grid system and fill in the values in the H (Haves) & W (Wants) columns. Perform diagonal subtractions. Review of Step 2: Have - % Isopropyl Alcohol in & Water as diluent concentration 0%. Want: 66% (v/v) Isopropyl, final volume of 60ml. H W U/P/R % 66 Parts of % 66% 0% 33 Parts of H2O Total wanted 1. Determine whether diluting or concentrating a liquid. a) If diluting, find the diluent. It s either 0% or some % lower than the wanted %. b) If concentrating, find the pure drug. It s either 100% or some % higher than the wanted %. Answer: Want to dilute a solution. Diluent is water. The Lab has 500ml bottle of % Isopropyl Alcohol in. You have been asked to prepare a concentration of 66% (v/v) final volume 60ml. H20 is the diluent. How much of the % (v/v) Isopropyl Alcohol in & how much water is needed to make 66% (v/v) Isopropyl with a final volume of 60ml. What is the% of water? Answer: 0%. 4. Set Ratio Proportions using values from U/P/R (use, parts, ratio) column. Using r/p (ratio proportions) to determine the amount (X) of % Isopropryl Using r/p to determine the amount (Y) of water X ml Y ml

5 5. Calculate Out the ration proportions Using r/p (ratio proportions) to determine the amount (X) of % Isopropyl 66 X ml ()(X) (66)() X 40 ml % Isopropyl in Using r/p to determine the amount (Y) of water 33 Y ml ()(Y) (33)() Y 20 ml of water This is the proof: The definition of %(v/v) Isopropyl ml pure alcohol 100 ml total volume Have: 40 ml of %(v/v) Isopropyl ml 100 ml (TV) X ml 40 ml and we have 20 ml of water added for TV of X 39.6 ml of pure Isopropyl in 39.6 ml X 100 X% 66% Isopropyl in & H2O ( TV) If you like the presentation Please add the comment You enjoyed the Robert & Dave show. Thanks