PyroCLEANTM

 

Endotoxin Decontamination

Endotoxin contamination represents a serious problem to both the pharmaceutical and tissue culture industry.  Nanogram quantities of this lipopolysaccharides are sufficient to turn multimillion dollar products into non-usable pyrogenic materials driving the cost of manufacture much higher than it should be. Traditional depyrogenation methods include either incineration at 260oC with dry heat or the use of high concentrations of acids or bases for prolonged periods of exposure.  Although, these methods are reasonable effective they are extremely expensive, time consuming, cumbersome, and in many cases represent a serious hazard to employees. Additionally, many commonly used materials will not tolerate these harsh conditions, e.g. certain rubbers, plastics, metals, etc.

PyroCLEAN represents a pharmaceutical biodegradable detergent which will solubalize endotoxin so it may be rinsed away with water, alcohol's or bases, alone or in combination which renders a pharmaceutical surface free of endotoxin. PyroCLEAN will also solubalize many light machine oils and silicone so they may also be rinsed away.

PyroCLEAN can also be used to depyrogenate micro and ultrafiltration membranes1 and chromatography columns2.

PyroCLEAN may be used alone or as an adjunct to existing cleaning methods.  Cleaning applications include, tanks, glassware, pharmaceutical stoppers, HPLC and Affinity Columns, plastics, implantable devices, pharmaceutical tubing, membrane filters, etc.

PyroCLEAN unlike other detergent based products, PyroCLEAN is traceable down to 4 X10-13g/ml using absorption at 270nm which provides a convenient method of detecting potential residuals.

PyroCLEAN is sold as a 4-10X concentrate, depending on application in liter quantities and is available either with or without  phenol red indicator for easier visualization on pharmaceutical surfaces.

ALerCHEK, Inc. also offers both endotoxin LAL based testing of materials and endotoxin consulting services.  This can take the form of verbal or on site visits if warranted.  After years of experience in this specialized area we can save your firm time, money and in many cases we can improve the quality and constancy of your products.

Product Description

Cat. Number

Unit Price

PyroCLEAN 4x Conc. w/indicator

I30103

$150.00/Liter

PyroCLEAN 4x Conc. w/out  indicator

30103

$150.00/Liter

PyroCLEAN (Bulk) w/ indicator

I30104

$805.00/12Liter

PyroCLEAN (Bulk) w/out indicator

30104

$805.00/12Liter

PyroCLEAN (Bulk) w/ indicator

I30105

$1200.00/5 gal

PyroCLEAN (Bulk) w/out indicator

30105

$1200.00/5 gal

Endotoxin Assays (quant. LAL-based)

inquire

$45.00/data point

Free Evaluation Samples and Application Advice Available Upon Request

1.Millipore/Amicon Centrifugal Concentrators (Please ask for product application protocols)

2.Everse, Johannes, Vandegriff, Kim D., and Winslow, Robert M. "Preparation, Purification, and Analysis of Human Hemoglobin", Methods in Enzymology. Vol. 231, Part B, Biochemical and Analytical Methods



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