GUIDANCE MATERIAL The following is a selection of reference documents relating to various aspects of Chemosafety.
®® Cytotoxic drugs and related waste risk management guide 2008
WorkCover New South Wales, July 2008
WorkSafe Victoria, January 2003
Workplace Health and Safety, Queensland Department of Industrial Relations, 2005
SHPA Committee of Specialty Practice in Oncology, J Pharm Pract Res 2005; 35(1); 44-52
Aust J Hosp Pharm 2000; 30(3): 116-17
National Health and Medical Research Council, Commonwealth of Australia 1999
Worksafe Australia, Australian Government Publishing Service, Canberra, December 1989
Australian Safety and Compensation Council (ASCC)
Australian Safety and Compensation Council (ASCC)
WorkSafe Victoria, Victorian Government
Model Regulations Volume 1, United Nations, New York and Geneva. 14th revised edition, 2005
Australian and New Zealand Clinical Waste Management Industry Group (anzcwmig), 4th Edition, 2004
®® Handling cytotoxic drugs in the workplace ®® Guide for handling cytotoxic drugs and related waste
®® SHPS Standards of practice for the safe Handling of cytotoxic drugs in pharmacy departments ®® Standards of practice for the transportation of cytotoxic drugs from pharmacy departments ®® National guidelines for waste management in the health care industry ®® Guide for the prevention of eye damage
®® Competencies for health surveillance (1998) ®® Guidelines for health surveillance (1995)
®® A guide to risk control plans, September 2001 ®® Recommendations on the transport of dangerous goods
®® Code of practice for the management of clinical and related wastes
GUIDELINES
Throughout this brochure, the NSW guidelines are referred to. For the latest information in all states: New South Wales
WorkCover NSW.................................................................................................www.workcover.nsw.gov.au Victoria
WorkSafe Victoria................................................................................................... www.worksafe.vic.gov.au Queensland
Workplace Health and Safety Queensland.............................................................www.worksafe.qld.gov.au South Australia
SafeWork SA...........................................................................................................www.safework.sa.gov.au Tasmania
Workplace Standards........................................................................... www.workplacestandards.tas.gov.au Western Australia
WorkSafe.............................................................................................www.commerce.wa.gov.au/WorkSafe
CONTENTS
WHAT ARE CYTOTOXIC DRUGS?................................................................................................ 02 PROTECTIVE PRODUCTS FOR SAFE HANDLING OF CYTOTOXIC DRUGS..................... 03 PERSONAL PROTECTIVE EQUIPMENT..................................................................................... 05 GOWNS................................................................................................................................................ 07 GLOVES............................................................................................................................................... 09 EYE PROTECTION.............................................................................................................................10 RESPIRATORS..................................................................................................................................... 11 SPILL KITS...........................................................................................................................................12 CHEMOSORB PADS...........................................................................................................................13 SPILL MATS.........................................................................................................................................13 RED SOLUBLE BAGS.........................................................................................................................14 LABELS..................................................................................................................................................15 CHEMOSAFETY IN THE PHARMACY...........................................................................................16
Cytotoxic drugs work by causing the death of certain type of cells and are used to treat conditions such as cancer, rheumatoid arthritis, multiple sclerosis and some ophthalmic conditions. Not all drugs prescribed for cancer are cytotoxic. Cytotoxic drugs are known to be highly toxic to non-target cells, mainly through their action on cell reproduction. Some have been shown to cause second cancers in cancer patients. Some have also been shown to be mutagenic (causing changes to DNA) or teratogenic (causing birth defects) in various experimental systems. Cytotoxic drugs are increasingly being used in a variety of health care and community settings, laboratories and veterinary practices for the treatment of cancer and other medical conditions, such as rheumatoid arthritis, multiple sclerosis and autoimmune disorders – eg psoriasis and systemic lupus erythromatosis.
“Generally, cytotoxic materials are identified by a purple symbol that depicts a cell in late telophase.” Occupational exposure to cytotoxic drugs and related waste may occur where control measures fail or are not in place. Exposure may occur through skin contact, skin absorption, inhalation of aerosols and drug particles, ingestion and sharps injuries. Exposure may occur when preparing drugs, administering drugs, transporting drugs, handling patient waste, transporting and disposing of waste and cleaning spills. Those most likely to be involved in these activities include nurses and medical officers, pharmacists, laboratory staff, cleaning, maintenance and waste disposal staff, carers, veterinary staff, ambulance officers and drivers. Cytotoxic Drugs and Related Waste – Risk Management Guide 2008 (WorkCover NSW)
02 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
PROTECTIVE PRODUCTS FOR SAFE HANDLING OF CYTOTOXIC DRUGS Cytotoxic drugs are used to treat a range of medical conditions including cancer, rheumatoid arthritis, multiple sclerosis and autoimmune disorders. A number of adverse health effects have been reported in those who prepare and/or administer cytotoxic drugs, where adequate risk controls to minimise exposure to the drugs have not been put in place. PD2008_059 Cytotoxic Drugs & Related Waste - Safe Handling in the NSW Public Health System.
The dangers associated with Cytotoxic Drugs have been well documented. Various guidelines have been developed to ensure the safe handling of these drugs. Your safety and protection is extremely important. At Clean Room Garments we offer a complete range of products that will provide you with maximum protection. These include: 1
Spill Kits that will control spills up to one litre.
2
Protective Garments, Gloves, Masks, Respirators and Eye Protection.
3
Labels for effective waste control and transportation.
For more detailed technical/product information or product samples please do not hesitate to contact your Key Account Manager.
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 03
COVERALLS & GOWNS Gowns are usually worn for tasks involving the administration of cytotoxic drugs and patient care. Coveralls are most commonly worn in drug preparation areas. Selection considerations for coveralls or gowns include: ®® Should be made of impermeable material ®® Should have a closed front and long sleeves with elastic cuff
HEAD COVERINGS ®® Head coverings should be worn to contain hair and minimise contamination. They should cover exposed hair, including beards and moustaches. ®® Hoods, caps and facial enclosures should not interfere with respiratory protection.
GLOVES ®® ®® ®® ®® ®®
Glove use is essential Gloves must be chosen to maximise protection by minimising permeability Gloves must be long enough to cover wrist cuffs of coveralls or gowns while arm is bent or stretched Choice of gloves currently includes purpose manufactured or manufacturer recommended; and surgical disposable gloves Operators not wearing special-purpose gloves should be double gloved
PROTECTIVE EYEWEAR ®® This is provided to prevent exposure to the mucous membranes of the eye from liquid splashes ®® Eye protection can be provided by goggles or protective eyewear with side shields
RESPIRATORY PROTECTIVE EQUIPMENT (RPE) ®® ®® ®®
Suitable RPE should be selected, used, stored and maintained as recommended in AS/NZS 1715: 2009 Selection, use and maintenance of respiratory protective equipment To contain cytotoxic spills which may generate aerosols, respiratory protective equipment with a particulate filter P2 (N95) is recommended Surgical respirators do not offer sufficient respiratory protection against exposure to powders, liquids or aerosols (particulates)
SHOE COVERS OR OVERSHOES ®® Shoe covers must be made of impervious material ®® Overshoes of a similar impermeable material as the coverall or gown ®® Disposable shoe covers do not provide sufficient protection from cytotoxic spills
04 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
Together with other control measures, the following personal protective equipment should be provided to those who prepare cytotoxic drugs: üü Impermeable coverall or gown üü Head covering üü Protective gloves üü Protective eyewear üü Respiratory protective mask üü Closed footwear & overshoes
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 05
Item Number
Product Description
Size
Qty Per Pack
Minimum Order Qty
BCAS
BIOCLEAN-C™ CHEMOTHERAPY PROTECTIVE APRON WITH SLEEVES
S, M, L, XL
40/CTN (35/XL)
1 CTN
2189PUS
PURPLE ULTRASHIELD GOWN ELASTIC CUFFS, CLIP CLOSURE AT NECK, TIE AT WAIST
SM, M, L, XL
1
1
PA64001Y
YELLOW DISPOSABLE CHEMO GOWN
1 SIZE
50/CTN
1 CTN
06 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
GOWNS
The following gown styles listed provide protection against hazardous drugs, most liquids and are suitable to wear when administering cytotoxic drugs.
CHEMOTHERAPY PROTECTIVE APRON WITH SLEEVES The BioClean-C™ chemotherapy protection apron with sleeves provides maximum protection against a range of cytotoxic drugs.
®® ®® ®® ®®
Manufactured using lightweight, low-linting and hard wearing CleanTough™ fabric. The apron features an adjustable neck fastening with tie tapes at the waist and ultrasonically bonded sleeve seams with protective tape and 100% polyester elasticated cuffs. Manufactured in a facility holding ISO 9001:2008 certification and processed to ensure ISO Class 4 and GMP Grade A compatibility. IPA resistant ink ensures that bags can be wiped down with cleaning or sterilising fluids without fear of cross- contamination from printing inks.
PURPLE ULTRASHIELD GOWN The Purple Ultrashield gown is made of 100% polyester with electro conductive fibre (ECF) Stripe, and can be laundered. This purple ultrashield gown has the benefit of being available under a rental program, reducing the requirement for large initial monetary outlays when purchasing. This gown has been designed and constructed with considerable thought for maximum protection to the wearer and has the following features:
®® ®® ®® ®® ®® ®® ®®
Custom manufactured from premium grade repellent polyester, providing an excellent barrier with proven protection against cytotoxic drugs. Proprietary processing – the gown can be laundered using our proprietary processing technique, whilst not wasting money or natural resources on single use disposable gowns. Our processing service is validated for the removal of cytotoxic drugs. Double needle stitched seams with enclosed overlocking, ensures the seams of your gowns have the same protective qualities as the entire gown. Rear neck clip closure presents a sealed front to the work area to fully protect the wearer. Waist tie is fixed on the side of the gown and easily ties to the back. Quality polyester knitted cuffs hold the gown in place – for ease of donning gloves. Purple coloured – easily identified as a gown for cytotoxic protection.
YELLOW DISPOSABLE CHEMO GOWN The yellow disposable CRG chemo gown is manufactured from an impervious poly-coated material and offers proven protection against cytotoxic drugs.
®® ®® ®® ®® ®®
Impervious Fabric – suitable for use with cytotoxic and other hazardous drugs. Elasticised cuffs – comfortable fit, improves ease and speed of donning gloves, hold gown in place. Waist tie – easily fastens at the back for a comfortable fit. One Size – enables bulk buying – providing economies of scale, and eliminates sizing issues. Low Price – save money, less risk to change over, and excellent value for money.
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 07
Item Number
Product Description
Size
Qty Per Pack
Minimum Order Qty
OPTXP-XS
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
XSM
100
10 PACKS
OPTXP-S
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
SM
100
10 PACKS
OPTXP-M
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
M
100
10 PACKS
OPTXP-L
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
L
100
10 PACKS
OPTXP-XL
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
XL
100
10 PACKS
OPTXP-XXL
OMEGA™ PRO-TECH PURPLE NITRILE GLOVES 12" BOXED - AMBIDEXTROUS
XXL
100
10 PACKS
BNPLS-5055
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
XSM = 5-5.5
10 PR
20 PACKS
BNPLS-6065
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
SM = 6-6.5
10 PR
20 PACKS
BNPLS-7075
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
M = 7-7.5
10 PR
20 PACKS
BNPLS-8085
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
L = 8-8.5
10 PR
20 PACKS
BNPLS-9090
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
XL = 9
10 PR
20 PACKS
BNPLS-1010
BIOCLEAN™ STERILE INDIGO PURPLE NITRILE GLOVES 12" PAIR PACKED
XXL = 10
10 PR
20 PACKS
08 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
GLOVES PURPLE NITRILE CHEMOSAFETY GLOVES Purple Nitrile Gloves are the latest development in Chemosafety protection. Formulated from 100% Nitrile (a synthetic polymer), the gloves are specifically designed to offer maximum protection, whilst providing the sensitivity required to safely perform delicate procedures. The long length Purple Nitrile Gloves have been tested for protection during administration. These purpose manufactured gloves are meticulously designed to be soft and remarkably comfortable to wear. The benefits of our Purple Nitrile gloves include:
100% Nitrile ®® ®® ®® ®®
Eliminates risk of an immediate type of hypersensitivity (Type 1) allergic reaction to latex proteins Superior strength and durability Resists permeation by a wider range of chemicals than natural rubber latex or vinyl of similar thickness Eliminates need to wear two pairs of latex gloves
Powderfree ®® Eliminates powder-associated transfer of chemical allergens ®® Eliminates powder-induced irritations or abrasions
Chemical Content ®® Lower level of chemicals used in manufacture reduces risk of irritant or allergic contact dermatitis (Type 5)
Functional Features ®® ®® ®® ®®
12” (30cm) cuff ensures extra protection Ambidextrous, with superior fit and comfort Tapes and labels do not stick or tear gloves Textured fingertips provide ideal grip for any conditions
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 09
EYE PROTECTION
CRG offers the Yukon disposable glasses that comply with AS/NZS 1337.1.2010 Personal eye protection – Eye and face protectors for occupational applications. These glasses feature:
®® ®® ®® ®®
Medium impact, anti-scratch lens Deep design allows the glasses to be worn over prescription spectacles 99.9% UV protection for outdoor wear One piece frame provides unobstructed 180° view
Item Number
Product Description
0401
YUKON - DISPOSABLE GLASSES
10 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
Size
Qty Per Carton
Minimum Order Qty
1 SIZE
12
1 CARTON
RESPIRATORS
A respirator is designed to protect the wearer from inhaling harmful dusts, fumes, vapours and/or gases. Respirators come in a wide range of types and sizes. It is critical that you select the respirator suited to your application, to ensure adequate protection is offered. Respirators range from economical, single-use, disposable masks to reusable models with replaceable cartridges. Under AS/NZS 1716 – Respiratory Protective Devices, P2 particulate filtering respirators must have a filter efficiency of at least 94% when tested with Sodium Chloride aerosol. The particle size of this aerosol has a mass median diameter of 0.3 to 0.6 microns with a range of particles in the 0.02 to 2 micron size range. This aerosol is delivered to the filter at a flow rate of 95litres/minute. Other factors such as the amount of air leakage between the respirator and face seal (respirator fit) and the amount of time the respirator is worn (wear time) also come into play when assessing respiratory protection. All three factors (Filtration, Fit and Wear Time) need to be considered when looking at application of respiratory protection options, not just the filter classification. CRG offers the following respirators compliant with the AS/NZS 1716 standard.
P2 RESPIRATOR WITH VALVE The 3M 8822 respirator provides lightweight, effective, comfortable, and hygienic respiratory protection against dust, mists, fumes and smokes. The cupped shape, twin strap design, foam nose seal and steel nose clip ensure a good facial seal over a range of face sizes. The unique valve and collapse resistant shell offers durable, comfortable protection, particularly in hot humid conditions.
P2 FLAT FOLD RESPIRATOR MASK An economical, P2 respirator.
P2 FLAT FOLD RESPIRATOR MASK WITH VALVE The inclusion of an exhalation valve improves wearer comfort.
Size
Packaging Configurations
Unit of Measure
Minimum Order Qty
P2 RESPIRATOR/VALVE (L/WGT)
1 SIZE
10 MASKS/BOX 10 BOXES/CTN (100 MASKS)
10 MASKS
10 BOXES
606020
P2 FLAT FOLD RESPIRATOR MASK
1 SIZE
1 MASK/PK 20 PKS/BOX (20 MASKS)
20 MASKS
1 BOX
606021
P2 FLAT FOLD RESPIRATOR MASK WITH VALVE
1 SIZE
1 MASK/PK 12 PKS/BOX (12 MASKS)
12 MASKS
1 BOX
Item Number
Description
8822
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 12
SPILL KITS HAZARDOUS DRUGS SPILL KIT CRG’s Hazardous Drugs Spill Kit is designed to provide maximum efficiency in times of emergencies. It contains all necessary items for immediate response to cytotoxic drug spills. The Hazardous Drugs Spill Kit is capable of controlling spills of up to 1 litre. It comes packaged in a purple drawstring carry bag which can be conveniently carried on your shoulder during the transportation of a patient to wards. It also allows nurses to tie the kit on trolleys for easy transportation. The kit also comes in an outer box to allow you to store it away. CRG’s Hazardous Drugs Spill Kit contains one of each of the following items (except where indicated in brackets):
®® ®® ®® ®® ®® ®® ®® ®® ®®
Purple Nitrile Chemosafety Gloves Medium (2 pairs) Purple Nitrile Chemosafety Gloves Large (2 pairs) P2 Respirator Mask Disposable Chemo Safe Gown Safeguard Shoecovers Safety Glasses Chemosorb Pad (2) Purple Cytotoxic Waste Bag Roar Wipes (4)
®® ®® ®® ®® ®® ®® ®® ®® ®® ®®
White Waste Bag Chemo Spill Kit Incident Report Blue Form Caution Sign Scoop & Scraper Cable Ties (2) Chemo Spill Procedure 21” Round Head Cover Purple Plastic Draw String Bag Clear Zip Lock Bag 6x9” 200ml Plastic Water Bottle
CHEMO ADMIN KIT The Chemo Admin Kit is a self contained kit ready for cytotoxic drug administration. The kit is ideal for home nursing, and for the use of chemotherapy in outlying wards, country hospitals and emergency procedures. The Chemo Admin Kit contains one of each of the following items:
®® ®® ®® ®®
Light-weight disposable barrier gown Purple Nitrile Chemosafety Gloves Medium Purple Nitrile Chemosafety Gloves Large Flat fold P2 Respirator Mask
Item Number
Product Description
Size
Qty Per Carton
Minimum Order Qty
4004CRG
BAXTER/CRG HAZARDOUS DRUGS SPILL KIT
1 SIZE
1
1 CARTON
4110
CRG CHEMO ADMIN KIT
1 SIZE
1
1 CARTON
12 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
CHEMOSORB PADS
The ChemoSorb Pad is a non-woven fabric with special dessicant granules impregnated into the fabric. The granules absorb liquids and turn them into a gel. The pads are designed to absorb a maximum of 500ml of liquid each and are equally effective with any liquid: Drugs, Water, Blood and other bodily fluids. Item Number
Product Description
Size (cm)
Qty Per Pack
Minimum Order Qty
BS0013
CHEMOSORB PADS
30 X 30
1
100 Packs
SPILL MATS
These low particulate absorbent spill mats are specifically designed to catch any spills or drips whilst preparing cytotoxic drugs in aseptic areas. The triple layer construction prevents any contamination from reaching the working surface. The mats are available individually double bagged and gamma irradiated to pass into the controlled environment. Each bag is easy to open with the Klertear feature. The Chemotherapy Spill Mat is ideal as a work surface for chemo preparation and administration and has the following features:
®® Unique three-ply dressing is functional and effective – sandwiches highly absorbent gauze between top layer of penetrable mesh and bottom layer of non-permeable plastic backing. ®® Top layer is a lint free penetrable mesh. In the event of a spill, the spill will soak through to the second layer and allows the operator to maintain a clean, dry work surface. ®® The third layer is a plastic barrier designed to contain the spill and to protect the work surface from contamination. ®® Due to the unique design, the Chemotherapy Spill Mat can be used for the entire shift and does not need to be changed after minor spills. ®® Non linting to eliminate hazard of air-borne contamination. Item Number
Product Description
Size (cm)
Qty Per Pack
Minimum Order Qty
0302
CHEMO SPILL MAT NON-STERILE
56 X 41
10/PK
5 PKS
3038030
KLERPACK STERILE CHEMO SPILL MAT
54 X 41
10/CTN
1 CTN
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 13
RED SOLUBLE BAGS
Soluble bags are high density translucent red polyethylene bags designed to prevent potentially contaminated garments (garments that may have been worn around potentially hazardous drugs or come into contact with human bodily fluids) from coming into contact with personnel or other dirty garments. These bags are an essential component of infection control procedures. Soluble bags cannot be dissolved from the inside by their contents, due to their water soluble vertical panel and tape construction. The polyethylene material that the bags are made of is recycled. They have an alginate-stitched seam, which when in a washing machine, dissolves, releasing the contaminated garments into the machine for processing. This avoids the need for any personnel to manually handle potentially contaminated garments prior to them being cleaned. Australian/New Zealand Standard™ AS/NZS 4146:2000 Laundry practice, Clause 2.4.1 Preparation of soiled linen for collection paragraph (a) states that: “In addition to being placed in suitable laundry bags, linen which is heavily soiled with blood or other bodily fluids (…) shall also be contained within suitable impermeable bags which are to be securely closed. (…)” N.B. The word “shall” denotes a mandatory requirement.
®® ®®
As part of CRG’s OH&S requirements it is essential that all customers processing potentially contaminated garments with us, return soiled garments within red soluble bags. Grossly contaminated garments should never be returned to CRG for processing. They should be disposed of according to your onsite hazardous waste disposal protocol.
Item Number
Product Description
Size (cm)
Qty Per Pack
Minimum Order Qty
WSSB710-990
RED SOLUBLE BAGS
71 X 99
25 BAGS/ROLL
1 ROLL
14 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
LABELS
Identification of Cytotoxic Hazards is imperative for safe handling of cytotoxic drugs in healthcare establishments. CRG provides a range of labels which:
®® Provide easy identification of cytotoxic drugs and waste. ®® Carry the purple symbol that has immediate recognition. ®® Adhere to sealed plastic bags for transportation of drugs from pharmacy to wards, waste, carry containers, etc. Item Number
Product Description
Size (mm)
Qty Per Pack
Minimum Order Qty
6001
LABEL - CAUTION HANDLING
50 X 120
100/ROLL
1 ROLL
6002
LABEL - CYTOTOXIC WASTE
50 X 120
100/ROLL
1 ROLL
6003
LABEL - CYTO PROTECTIVE PRODUCTS
TBA
100/ROLL
1 ROLL
6004
LABEL - CAUTION CYTOTOXIC
40 X 60
100/ROLL
1 ROLL
CAUTION CYTOTOXIC
CYTOTOXIC WASTE
HANDLE WITH CARE WEAR GLOVES AND PROTECTIVE CLOTHING WHEN HANDLING
DISPOSAL BY HIGH TEMPERATURE INCINERATION
CHEMOSAFETY
CHEMOSAFETY
CHEMOSAFETY
CAUTION
PROTECTIVE PRODUCTS FOR SAFE HANDLING PURPOSES
CYTOTOXIC
CLEANROOM GARMENT CHEMOSAFETY GUIDE / 15
CHEMOSAFETY IN THE PHARMACY
CRG understands that handling cytotoxics in the pharmacy is quite different to a ward or administration environment. CRG have a range of products designed to cater for chemosafety within the cleanroom environment.
COVERALLS Coveralls provide maximum control of particulate and microbial contamination, making it ideal for critical applications. Combined with the appropriate head and shoe coverings the coverall provides maximum body coverage. In Oncology Pharmacies where protection from cytotoxic drugs is required, coveralls provide maximum protection for the operator, whilst adhering to cleanroom specifications. The range of disposable garments supplied by CRG includes coveralls with hood or with a collar, a hood (where separate head cover is required), lab coat, sleeve covers and overboots. The garments are lightweight, hard-wearing and compatible for use in ISO Class 4 cleanrooms. They are available as sterile or non-sterile.
16 / CLEANROOM GARMENT CHEMOSAFETY GUIDE
STERILE ALCOHOLS The most widely used contamination control product in sterile pharmacies is alcohol. During production and after cleaning and disinfection, all equipment used should be wiped down with sterile alcohol.
CRG’s Shield Medicare range of sterile alcohols is available as either 70% IPA or denatured ethanol (IMS), blended with either WFI or deionised water. They are cleanroom processed, 0.2 micron filtered and terminally sterilised by gamma irradiation.
STERILE & NON-STERILE CHEMICALS CRG’s Shield Medicare and VAI sterile and non-sterile chemical ranges cover all of your cleaning needs. Whether it is a phenolic or a quarternary ammonium that you require, CRG is able to not only provide you with the product, but our Key Account Managers can also help you choose a rotational program that will rid your cleanroom of all the types of contamination. Shield Medicare’s ready-to-use concentrations are available as either spray systems fitted with the SteriShield Delivery System, which ensures the sterility of the contents is preserved throughout use, or in a 5 litre capped container. The disinfectants can also be applied by using a fogging system connected to an existing compressed air supply or a by a fully validated spray device which is autoclavable. The VAI sterile range is manufactured in an FDA approved Class 100 aseptic facility. All sterile chemicals are aseptically filled and then gamma sterilised. The chemicals are double bagged and supplied with full documentation.
DURX WIPES All processes within a pharmacy environment require all contamination to be either eliminated or minimised. Berkshire’s Durx Wipes are designed specifically for such an environment and are ideal for critical and sterile production processes. CRG’s Durx Wipes are available sterile or non-sterile to ensure critical areas maintain their required grade of cleanliness. CRG’s Durx Wipes are made of a non-woven polyester/ cellulose blend and are suitable for most cleanroom applications.
STERILE GLOVES CRG’s Sterile Latex and Nitrile gloves are specially designed to provide maximum protection for both personnel and the product. They are made from superior strength natural rubber latex, or nitrile, and contain minimal natural proteins so as to reduce the risk of allergy to the wearer. Gloves are gamma irradiated and proprietary processed with an “Oxyglaze” finish, which make them easier to don, whilst enhancing their liquid permeation resistance. They have tapered beaded cuffs for extra durability and textured grip pads on the fingertips for greater dexterity. The gloves come packaged in pairs to ensure sterility is maintained. Hypoclean gloves meet and exceed all relevant regulatory requirements.
TACKY MATS Contamination control peel off mats offer long lasting protection against microbials. Placing mats in high traffic areas and entryways significantly decreases the amount of contamination brought in. Removal of the protective film on the bottom and top of the mat is all that is required to install it. As footwear or wheels pass over the mat surface, the pressure-sensitive adhesive traps dirt and holds it for disposal. The mats guarantee maximum efficiency when placed at the entry way of your cleanroom or hospital environment. Each time a layer is contaminated, simply remove it to reveal a fresh layer, ready for use. Individually numbered tabs aid in the removal of one layer at a time and indicate how many layers remain on the mat.