Pharmacy and IV Therapy

Quality Assurance (USP <797>):
Cleanroom Contamination Control, Testing

 

 

Contamination Control Cleaning products

QI Medical Testing Products

 

 

 

 

 

 

CONTAMINATION CONTROL CLEANING PRODUCTS

A complete line of wipers and associated products to meet specific cleanroom requirements. The implementation of USP <797> in Hospital Pharmacies and Compounding Pharmacies requires the usage of appropriate clean room consumables. The challenge is to implement cleaning protocols using the appropriate consumables that are best suited to your Cleanroom and Laminar Flow hood environment and applications.

USP <797> compliant Pharmacies will be required to:
- wipe down every bottle, syringe, and vial that enters the cleanroom
- clean and sanitize all buffer room carts, equipment, hoods, walls,
  surfaces and floors
- document all compounding activities
- sanitize gloves
- conduct sterility and bacterial endotoxin testing for high risk compounding
  note: information on QA Testing products in “QI Medical Products” section
  to follow.
- label in compliance with storage requirements
- clean and sanitize the cleanroom anteroom and shelving

Our product offering is from ITW Texwipe® - the leader in supplying consumables for contamination control in critical environments.

Wipers include the following options:
- Dry wipers – TX629 (low lint) or TX1009 (lint free) as the most
  cost-effective for standard laminar flow hood applications.
- Sterile Dry wipers – TX3210, TX3211.
- Pre-wetted wipers with 70% isopropyl alcohol – TX1065.
- Sterile Pre-wetted wipers with 70% isopropyl alcohol – TX3217, TX3214,
  TX3280.

Associated Products:
- Contamination Control mats – AMA254513WW01.
- Cleanroom mops – TX7108 and covers- TX7118, TX718H, TX7026.
- Sterile 70% Isopropanol – TX8270, TX3270, TX3290.

Please find below a general “Product Selection Guide” designed by Texwipe to meet the USP <797> mandate followed by product listing.

For more information and data sheets on each particular cleaning control product go to our manufacturer website at www.texwipe.com

Select the heading “Data” at the top then select product category (eg wipers) then select the catalogue number (eg TX629 VersaWipe® or TX1009 Alphawipe®) This will include detailed product description, features and benefits, applications, list of similar family of products, performance and contamination characteristics.

See this data information below for cat TX629 which is one of the basic low cost wipers recommended for cleaning of standard Hospital laminar flow hoods and associated components.

TX629 VersaWipe® Datasheet

Material Safety Data Sheets are also available from the TexWipe website.

 

 

 

QI MEDICAL TESTING PRODUCTS

Quality Assurance Testing products for routine testing of the laminar flow area; validation and monitoring of aseptic technique and end product testing of I.V. admixtures including TPN. Healthmark is the Canadian Distributor for QI Medical, the leading specialty provider of Quality Assurance Testing products.

If you would like more detailed information please contact Healthmark to receive a Quality Assurance Testing “Procedure Package” For specific clinical or procedural questions please contact Mr. Hilary Hedmen directly at QI Medical - phone 1-800-837-8361 or by email at info@qimedical.com. QI Medical also has links to various related Associations and Regulatory bodies at their website www.qimedical.com. To view pictures and "Directions for Use" by product go to QI Medical's US price list and click on the product code.

Quality assurance 1

Staff Validation: Aseptic Technique Test Kit
-
Cat. No. Description Case Size
GM7020 PATT™ Personal Aseptic Technique Test
Includes: 5 – 20ml vials with TSB (GM0200), 5 partially filled 100ml minibags with TSB (GM1400), test procedures and result log. 		5/cs
GM7030 PATT™ II Personal Aseptic Technique Test
Includes: Same as above plus 5 ampoules with TSB		 5/cs

 

ChemoTest™
Validate the technique of health care workers who manipulate hazardous drugs. Uses fluorescein dye and a UV light to detect breaks in safe technique and effectiveness of hazmat clean up procedures. The ChemoTest verifies the safe preparation of hazardous drugs using specific devices and negative-pressure containment techniques and validates correct use of safety equipment, spill cleanup kits, and disposal procedures.
-
Cat. No. Description Case Size
CT9530 3mL and 50mL vials 5/cs
CT9000 Mini Ultra Violet light, for use with ChemoTest #CT9530. Uses 4 AA batteries, not included each

 

Staff Validation: GroMed™
Suitable for initial and ongoing staff validations. Gromed™ is a test requiring repeated manipulation that closely resembles a complex I.V. admixture procedure.
-
Cat. No. Description Case Size
GM0200 Gromed™ Tryptic Soy Broth Media – 20ml vials 20/cs
GM2000 Gromed™ Tryptic Soy Broth Media – 100ml vials 10/cs
GM1400 Gromed™ Tryptic Soy Broth Media – 100ml bag with needle and spike port 10/cs
GM5000 Gromed™ Tryptic Soy Broth Media – 500ml bag with needle and spike port 10/cs

 

Environnemental Status
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Cat. No. Description Case Size
ET1000 Envirotest™ Media Paddles
Tryptic soy auger, double sided paddles. Microbial contamination monitoring of the laminar flow area on a routine basis. Suitable for air sampling and surface testing.		 10/cs

 

Laboratory Grade Incubator
-
Cat. No. Description Case Size
QL10-140 Incubator
13” W x 11”D x 15”H, 0.7 cubic feet		 each

 

Endotoxin Test Kit
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Cat. No. Description Case Size
PT5000 Pyrotest Endotoxin Test
Used to confirm that compounded liquids do not exceed acceptable levels of endotoxins (pyrogens per USP standards)		 5 per case
INC004 Pyrotest Incubator Rack
Pyrotest vial incubator block for 4 vials, aluminum		 each

 

End Product Testing
-
Cat. No. Description Case Size
TJ31000 QT Junior™ System
0.22 micron contamination tester
A cost effective, full filtration system for testing large and small volume sterile admixtures including clear TPN solutions. Large 17cm2 filter provides rapid flow and resists clogging. One piece system for simplified connections and reduced potential for contamination. Universal spike inlet and male luer lock outlet. Each test kit includes tester, 20ml vial of TSB media, gummed label and log. For vacuum or gravity transfers.		 20/cs
TJ3200 QT Junior™ System
0.22 micron contamination tester
A cost effective, full filtration system for testing large and small volume sterile admixtures including clear TPN solutions. Large 17cm2 filter provides rapid flow and resists clogging. One piece system for simplified connections and reduced potential for contamination. Universal spike inlet and spike port outlet for use in-line with any automated pharmacy dispensing pump (ie. PharmAssist Pump). Each test kit includes tester, 20ml vial of TSB media, gummed label and log. 		20/cs
QT1000 Quiktest™ System
For testing microbial contamination in large volume TPN admixtures containing lipid emulsions (ie. “3 in 1” formulations)		 10/cs
TM6000 QT Micro™
Non-vented female luer cap. For testing small volume (oncology,etc.) injectables.		 10/cs
TM6100 QT Micro™
Non-vented male luer cap. For testing small volume (oncology, etc.) injectables		 10/cs
GM8000 TuffTest™
Contamination tester for suspensions and emulsions
4/cs