Hospital Pharmacy Isolator Solutions for USP <797> Compliance from Esco

Hospital Pharmacy Isolator Solutions for USP <797> Compliance from Esco

Contents 1. Introduction 2. Clean Air Devices and Isolators 3. Cytotoxic Exposure 4. Esco Pharmacy Isolator (Positive Pressure Model) - Main Features - Isolator Airflow - Maximum Patient Protection and Sterility - Ergonomic Enhancements - Isolator Construction - Microprocessor Control - Factory Testing and Validation 5. Isolator Operating Protocol

Introduction Pharmacy is the health profession that links health science with chemical science, and it is charged with ensuring the safe use of medication. Pharmacies: Compound and dispense medication in accordance with physician s instructions. Provide patient care services including reviewing medications and providing drug use information.

Introduction Prescription Administration Order to Nurses Order to Pharmacy Preparation of Worksheets/labels Preparation of drugs

Introduction Pharmacy compounding is the practice of preparing drugs in new forms and is one of the pillars of new drug development. Physicians often prescribe compounded medicines for patients with unique health needs, because they are able to tailor a prescription to each individual patient and best meet their needs.

Introduction Compounding is indispensable in the following situations: Patients requiring limited dosage strengths and dosage forms (e.g., infants) Patients with drugs allergies to certain ingredients Veterinary medicine Pediatrics (e.g., making a medicine more palatable to children with flavor additives) Home health care

Introduction Brutal incidents involving pharmacy compounding: Georgia, USA, March 2001 4 patients hospitalized-severe adverse reactions Ingested a compounded thyroid medication 1,000 times ordered dose Florida, USA, July 2001 Aerosol medications contaminated and have little or no active ingredient, 3 patients died Pharmacists and others convicted of defrauding Medicare North & South Carolina, USA, September 2002 1 patient died & 3 suffer adverse event of fungal meningitis Source contaminated Methylprednisolone These incidents were an alarm for pharmacies to re-evaluate present practices and controls.

Introduction A compounded sterile preparation (CSP) is a dosage unit with any of the following characteristics: Preparations prepared according to the manufacturer's labeled instructions. Preparations containing non-sterile ingredients/ components/ devices that need to be sterilized before use. U.S Pharmacopoeia (USP) is a private organization formed in 1820. Current members include: Accredited schools of medicine and pharmacy State medical and pharmacy associations Government agencies, consumer organizations and others

Introduction USP <797>, enacted Jan 1, 2004 was written to improve the compounding of sterile products. It is the first official and enforceable requirement for CSPs The Chapter s requirements are applicable in all practice settings where sterile preparations are compounded By setting standards, requirements, and procedures for CSPs, USP <797> reduces the potential for contamination caused by environmental contamination, pharmacist error, lack of quality assurance, incorrect beyond-use dating, and other factors.

Introduction Specific issues USP <797> addresses: The responsibility of compounding personnel to ensure that CSPs are prepared, stored, dispensed, and distributed safely Contamination risk levels Procedures to verify the accuracy and sterility of CSPs Personnel training and evaluation Verification of Automated Compounding Devices (ACDs) Environmental quality and control

Clean Air Devices and Isolators USP <797> engineering control requirements: Laminar flow or biological safety cabinet in an ISO Class 7 cleanroom An isolator with work zone cleanliness of ISO Class 5 (cleanroom not required)

Clean Air Devices and Isolators Factors Which Influence Sterility of the Work Zone Cabinet placement, i.e. -Away from doors -Away from pedestrian traffic Operator technique: i.e. -Gloves over cuffs -Aseptic technique Environmental factors i.e. room air cleanliness Open Front Laminar Flow and Biological Safety Cabinets Heavily Dependent Heavily Dependent Heavily Dependent Air-Tight Isolator Independent Less Dependent Less Dependent

Clean Air Devices and Isolators Isolator Types and Classification Esco offers 3 types of isolators for varying applications Pressure Regime Positive Negative (Re-Circulating) Negative (Total Exhaust) Non Hazardous Compounding Hazardous Compounding (e.g. Chemotherapy) Hazardous Drugs which May Volatilize Yes Yes Yes No Yes Yes No No Yes 4 / 1.2m positive pressure model may be ordered in Oct 2007 with deliveries commencing in Nov / Dec 2007

Clean Air Devices and Isolators 5-10% (exhaust back to the room) 80-90% Re-circulating Air Positive pressure inside work zone maintains sterility even in case of a breach in the barrier. Suitable for non-hazardous compounding applications :TPN (Total Parental Nutrition); eye-drops; infusion; syringes, etc. Positive Pressure Model

Clean Air Devices and Isolators 10-20% (exhaust back to the room) 80-90% Re-circulating Air Negative pressure inside work zone maintains operator protection even in case of a breach in the barrier: Suitable for compounding of hazardous drugs which will not volatilize i.e. Chemotherapy Negative Pressure Model (Recirculating)

Clean Air Devices and Isolators Connected to Exhaust 100% exhaust Negative pressure to ensure operator s safety even in case of breach of barrier isolation system Suitable for compounding of hazardous drugs which may volatilize i.e. Chemotherapy Negative Pressure Model Total Exhaust

Cytotoxic Exposure Four routes of Cytotoxic Exposure: Inhalation Dermal absorption Ingestion of contaminated foodstuffs or mouth contact with contaminated hands Accidental injection

Cytotoxic Exposure Acute Gastrointestinal i.e. Nausea Irritation to eyes, mucous membranes Respiratory occupational asthma to mitoxantrone Dermatological i.e. rashes, dryness, irritation, hair loss Chronic Mutagenecity Developmental and reproductive effects i.e. increased fetal loss, low birth weight, infertility Cancer Risks Negative pressure isolators eliminate most of the four routes of cytotoxic exposure; hence, reduce the risk to personnel.

Esco Hospital Pharmacy Isolator Positive Pressure Model

Esco Hospital Pharmacy Isolator Features and Benefits ULPA filters with a typical efficiency of 99.999% at 0.1 to 0.3 microns provide superior ISO Class 3 air cleanliness, 100 times better than competing products. Work zone and pass-thru are under positive pressure relative to the external environment in order to maintain sterility in case of a breach in the barrier isolation system. Robust dual-wall construction. All positive pressure work zones are surrounded by negative pressure plenums at the sides and back for guaranteed safety. Sentinel Gold Microprocessor controller supervised all functions and monitors airflow and pressures in real-time.

Esco Hospital Pharmacy Isolator Features and Benefits Angled front and oval gloveports improve reach and comfort. Safe-change cuff rings permit glove changes with zero risk of contaminating the work zone. Easy-to-clean one piece work zone liner with no crevices. External surfaces are coated with Esco Isocide antimicrobial coating to protect against surface contamination and inhibit bacterial growth. Isocide eliminates 99.9% of surface bacteria within 24 hours of exposure. Optional sharps disposal system improves workflow. Optional hydraulic stand enables work height adjustment.

Esco Hospital Pharmacy Isolator Positive Pressure Isolator Airflow ULPA-filtered laminar airflow in work zone and pass-thru ensures ISO Class 3 cleanliness. Air in work zone and pass-thru is pulled below the work surface and behind the work zone into the blower plenum. This combines with some ambient air entering through an inlet filter. 90% of the total is re-circulated as laminar airflow in the work zone and pass-thru. 10% of the total is exhausted through an ULPA filter to prevent heat build-up.

Esco Hospital Pharmacy Isolator Isolator Filtration Advanced separatorless mini-pleated ULPA filters are tested to >99.999% efficiency for 0.1-0.3 micron particulates, significantly better than conventional HEPA filters. ISO Class 3 air cleanliness in work zone, 100 times better than competing products. Clean Air Recovery Laminar airflow within work zone and pass-thru enables recovery of chamber atmosphere to ISO class 3 conditions within 3 minutes. Entire work zone air is changed 20-30 times per minute.

Esco Hospital Pharmacy Isolator Pass Thru, Vertical Sliding Inner Door Minimizes ingress of contamination into the work zone during transfer procedure compared with conventional swing door design. Maximizes the effective work area in the work zone.

Esco Hospital Pharmacy Isolator Horizontal Sliding Tray Eliminate having to reach into the pass-thru Minimizes operator fatigue during transfer procedures

Esco Hospital Pharmacy Isolator Optional Sharps Disposal System Enables smoother work flow and minimizes cross contamination. Sharps may be disposed through the work surface into disposal bins while minimizing contamination of the work zone.

Esco Hospital Pharmacy Isolator Optional Sharps Disposal System Interface between sharps disposal bin and isolator is aerosol tight to avoid ingress of contamination during the disposal operation.

Esco Hospital Pharmacy Isolator Safe-Change Cuff Rings Glove changes with no risk of contaminating the work zone. 1 2 Push old glove into the sleeve Remove both O-rings

Esco Hospital Pharmacy Isolator Safe-Change Cuff Rings Glove changes with no risk of contaminating the work zone. 3 4 Move the bead of the old glove to the forward groove New glove is stretched over the old glove, with its bead in the rear groove

Esco Hospital Pharmacy Isolator Safe-Change Cuff Rings Glove changes with no risk of contaminating the work zone. 5 With the new glove in place, the bead of the old glove is gradually eased out of its place and into the sleeve for removal. O-rings are secured.

Esco Hospital Pharmacy Isolator Ergonomic Enhancements Ergonomically styled sloped front reduces glare and allows for easier reach into the work area. Oval shaped gloveports improve reach into the work zone compared with conventional circular ports.

Esco Hospital Pharmacy Isolator Ergonomics Enhancements Optional hydraulic stand enables the work surface height to be adjusted to fit the operator, for both sitting and standing operation. Common surgical gloves attach to the cuff ring and may also be used, depending on operator preference. Push-bar handle enhances mobility.

Esco Hospital Pharmacy Isolator Isolator Construction Cabinet interior is constructed of durable and pharmaceuticalgrade 304 stainless steel Single piece stainless steel work surface is easy to clean.

Esco Hospital Pharmacy Isolator Isolator Construction Raised edges on all sides with large radius corners to contain spillage and simplify cleaning Work zone has no welded joints to collect contaminants or rust

Esco Hospital Pharmacy Isolator Isolator Construction Hinged access window can be opened fully for loading large equipment and for cleaning purpose

Esco Hospital Pharmacy Isolator Isolator Construction Cabinet exterior is constructed of industrial-grade electrogalvanized steel External surfaces are coated with Esco ISOCIDE antimicrobial coating to protect against surface contamination and inhibit bacterial growth

Esco Hospital Pharmacy Isolator Microprocessor Control Sentinel Gold Controller with multi line LCD display Work zone and pass-thru pressures and downflow velocity are monitored with alarms and displayed on the LCD screen.

Esco Hospital Pharmacy Isolator Factory Testing and Validation Filter Leak Tests verify the integrity of the ULPA filters as-installed Downflow Velocity Tests verify adequate laminar air flow velocities Pressure Test measures work zone and pass-thru pressures Particle Counts (Air Cleanliness Tests) verify air cleanliness in accordance with ISO 14644-1

Esco Hospital Pharmacy Isolator Factory Testing and Validation Product Ingress and Egress Tests determines if the isolator work zone can maintain ISO Class 3 during transfer procedures Recovery Time Test determines the amount of time the main chamber takes to recover to ISO Class 4 in the event of a contamination event Breach Test verifies product protection in case of a glove failure. Operator Comfort Tests include noise, light and vibration.

Isolator Operating Protocol Basic Laboratory Practice Wear gloves: regular changing of gloves, double glove Wear gowns: vinyl coating, polyethylene coating recommended Wear masks: N-95 mask when compounding Shoe cover and hair cover Wash hands regularly Cleaning and Disinfection Cleaning and disinfecting the isolator at the beginning of each shift Cleaning and sanitizing the interior of the isolator between CSPs to avoid cross contamination Cleaning the background environment

Isolator Operating Protocol Tools for Cleaning and Disinfection Wipers and Mops Polyester knit fabrics used for wipers and mop covers will not contaminate isolator. They are the best choice for non-linting and non-shedding materials. Wipers can be wetted with: Detergents to clean/disinfect the isolator Deionized water or 70% IPA to remove residual cleaning agents / disinfectants

Isolator Operating Protocol Isolator Cleaning and Disinfection Cleaning Remove any residues and soils produced from the prior shift s activity using small flat surface mops, wipers, swabs and detergents Rinsing Following Cleaning After cleaning, detergent residues are removed from the surfaces with wipers or mops that have been wetted with sterile deionized water or sterile 70% IPA Disinfection The same procedures are followed for disinfection, except that liquid disinfecting agents are substituted for detergents i.e. quaternary ammonium compounds ( quats )

Isolator Operating Protocol Isolator Cleaning and Disinfection Rinsing Following Disinfection After disinfection, disinfecting agent residues are removed from the surfaces with wipers or mops that have been wetted with sterile deionized water or sterile 70% IPA Gaseous Sterilization If required, the isolator can be sterilized with a suitable sterilant such as Vaporized Hydrogen Peroxide (VHP) Cleaning and Disinfection Between CSPs Wipe the work surface of the isolator with 70% IPA Pre-wetted wipers may be used, if available Gloved hands should be wiped to prevent cross contamination

Isolator Operating Protocol Pre-Compounding Procedures Verify the isolator was shut down by the previous user. The following record keeping processes can be utilized: Check list Sign-off PC log Tagging Check the gloves for any breach before starting because gloves are prone to wear. Wipe down the interior of the isolator.

Isolator Operating Protocol Aseptic Compounding Process Proper planning before the materials are placed into the isolator. Organize the necessary materials for compounding and placing them in the pass-thru. Wipe down surfaces of items. Allow pass-thru air to purge before the inner side door is opened. In order to maintain air cleanliness inside the chamber, the two doors should not be opened at the same time. Place items in the work zone and wipe down. Verify all items required for the compounding session are in the work zone.

Isolator Operating Protocol Aseptic Compounding Process Use proper aseptic technique. Discard sharps in an approved sharp container after use. Remove completed products via the pass-thru. Label products before logging and delivery to patients. Compounding session is complete. Post-Compounding Procedures Thoroughly sanitize the interior (refer to cleaning procedures) in order to prevent residual compounds from contaminating the next process. Shut down the isolator if desired.

Isolator Operating Protocol Reference links European Association of Hospitals Pharmacists http://www.eahponline.org/ Pharmacy Practice News http://www.pharmacypracticenews.com/ Clinical Pharmacy Europe http://www.pharmacyeurope.net/ Hospital Pharmacy Europe http://www.campden.com/default.asp?ptid=3&pid=2&pgid=1

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