Contec Healthcare

Leading the way in contamination control products for use in critical environments

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USP Chapter <825> is intended to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals for humans and animals that occur as part of state-licensed activities (e.g., the practice of pharmacy and the practice of medicine). Chapter <825> applies to all practice settings where radiopharmaceuticals are prepared, compounded, dispensed, or repackaged. Practice settings consist of state-licensed nuclear pharmacies, federal nuclear pharmacy facilities, and other healthcare facilities, including, but not limited to nuclear medicine departments in hospitals and clinics, nuclear cardiology clinics (fixed site or mobile) and other specialty clinics.

USP Chapter <825>

The United States Pharmacopeia (USP)

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EPA-Registered Disinfectant Cleaners

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Challenges and Solutions

Contec’s Solutions for Your Challenges

Challenge 1

Solutions

Compounding Sterile Radiopharmaceuticals

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The most important factor for maintaining sterility is the avoidance of touch contamination.

Critical Site® Sterile Wipes SterileSorb™ Wipes Contec® Sterile 70% Isopropanol

Contamination Control

Contec ® Prep Mat

Radioactive Material (RAM) contamination (e.g., spills, drips, sprays, volatility) is an important concern for radiation protection. Various techniques and materials may be used by handlers of radiopharmaceuticals to minimize radioactive contamination.

Challenge 2

Solution

Personnel Qualifications, Training, and Hygiene

Contec® CritiGear™ Sterile Nitrile Gloves Contec® Healthcare Low-Lint Hand Drying Wipes Amplitude™ EcoCloth™ Wipes Contec® Contec® CritiGear™ HD Chemo Gowns

Individuals entering a compounding area must be properly garbed and must maintain proper personal hygiene to minimize the risk of contamination to the environment and/or radiopharmaceuticals.

Challenge 3

Solutions

Personnel must prove competency, as applicable to their job functions, prior to performing radiopharmaceutical aseptic tasks that are beyond immediate use. These qualifications must be completed and documented initially and then successfully repeated at intervals.

Challenges and Solutions

PeridoxRTU® Sporicidal Disinfectant and Cleaner Contec® Sterile 70% Isopropanol Amplitude™ EcoCloth™ Wipes Sanotex® Environmental Surface Wipes

Placement and Movement of Materials

All items must be wiped with low-linting wipers and an appropriate disinfectant by personnel wearing gloves before they are brought into the clean side of ante-room(s), pass-through(s), into a Segregated Radiopharmaceutical Processing Area (SRPA) or an ISO 5 PEC.

Challenge 4

Solutions

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Cleaning and Disinfecting

PeridoxRTU® Sporicidal Disinfectant and Cleaner (available in sterile and nonsterile)

Cleaning Equipment

dry, presaturated, sterile and nonsterile

Supplies

(Section 7.6)

Cleaning and Disinfecting Items from Patient Care Area

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PeridoxRTU® Sporicidal Disinfectant and Cleaner Sanotex® Environmental Surface Wipes Contec® Sterile 70% Isopropanol PROSAT® Sterile™ PS-911EB or Healthcare equivalent

(Section 7.5)

Disinfecting Critical Sites

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Contec Product Solutions:

(Section 7.4)

Disinfecting supplies for Classified Ares and SRPAs

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PeridoxRTU® Sporicidal Disinfectant Cleaner Amplitude™ EcoCloth™ Wipes Contec® Sterile 70% Isopropanol PROSAT® Sterile™ PS-911EB

Contec Product Solutions:

Contec® Critical Site™ Sterile Wipes

Contec Product Solutions:

Download Contec's USP <825> Guide

Standards for Radiopharmaceuticals

Chapter <825> applies to all practice settings where radiopharmaceuticals are prepared, compounded, dispensed, or repackaged. Practice settings:

State-licensed nuclear pharmacies Federal nuclear pharmacy facilities Other healthcare facilities, including, but not limited to nuclear medicine departments in hospitals and clinics, nuclear cardiology clinics (fixed site or mobile) and other specialty clinics

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Overview

USP CHAPTER <797>

USP CHAPTER <800>

USP CHAPTER <825>

USP Chapter <825> intends to provide uniform minimum standards for the preparation, compounding, dispensing, and repackaging of radiopharmaceuticals for humans and animals that occur as part of state-licensed activities (e.g., the practice of pharmacy and the practice of medicine).

effective against blood-borne pathogens

Contec ® Healthcare TB1-3300™ One-Step Disinfectant Cleaner (available sterile and nonsterile)

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PREempt® Plus (nonsterile)

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EasyReach™ Cleaning Tool (to be used with EasyReach Cleaning Pads)

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Klean Max™ Wall Washing System

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Contec® MicroCinch™ Mop

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Contec Product Solutions:

PROSAT® Sterile™ HCPS0002IR Wipes

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Amplitude™ EcoCloth™ Wipes

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Sanotex® Environmental Surface Wipes

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Contec Product Solutions:

Contec® Critical Site™ Sterile Wipes

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Sanotex® Environmental Surface Wipes (to be used with PeridoxRTU)

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"Disposable absorbent pads are commonly used to contain such radioactive contamination, and when used in an ISO Class 5 PEC, the pads must be clean and low-lint."

SterileSorb™ Wipes

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Contec® Sterile 70% Isopropanol

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USP <825>

Contec Healthcare

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Overview

USP CHAPTER <797>

USP CHAPTER <800>

USP CHAPTER <825>

Contec Product Solutions:

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Contec Product Solutions:

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