New Alconox Blog



Thursday, December 20, 2007


What is the GHTF?

Directly taken from, The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices, as well as promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices.

In this regard, Alconox aqueous cleaners are formulated to scrupulously clean medical devices to help manufacturer meet specified regulations, for more information please visit

Tuesday, December 18, 2007


What is the objective of the ICH?

According to, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.

In this regard, keeping manufacturing equipment clean is necessary to avoid cross contamination. To ensure safety requirements are met and to maintain a high standard of quality for products, many pharmaceutical manufacturers use Alconox brand products for critical cleaning. Learn more about Alconox aqueous cleaners and validation support offered by Alconox critical cleaning experts! Visit for more information.

Thursday, December 13, 2007

Cleaning Validation Information

What is a definition of cleaning validation? Does Alconox provide cleaning validation support for Alconox brand cleaners?

Cleaning Validation - Documented evidence with a high degree of certainty that a cleaning process will consistently produce product meeting its predetermined quality attributes. Quality attributes are typically those related to potentially contaminating residues.

Alconox, Inc provides validation support on all Alconox brand cleaners to assist in meeting cGMP guidelines. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, and has dedicated chapters to Cleaning Validation (Chapter 8) and to Measuring Cleanliness (Chapter 10). For more information or get your free copy of The Aqueous Cleaning Handbook visit,

Tuesday, December 11, 2007

Calculating Cleaning Agent Safety Based Limits

Does Alconox provide information on calculating cleaning agent safety based limits?

Alconox, Inc Pharmaceutical Cleaning Validation Method References has an entire section dedicated to cleaning agent safety based limits. Please visit here for more information:

Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. If the calculated limit is found to be higher than a less than 10 ppm carryover to the next batch, then the limit can be set to the more stringent 10 ppm carryover level for the safety based limit.

For additional information, the Alconox Technical Team has also written The Aqueous Cleaning Handbook, which in Chapter 10 discusses Measuring Cleanliness. For more information on the Handbook visit

Thursday, December 06, 2007

Electronics Cleaning with no Hazardous Chemicals or Volatile Solvents

Why is it beneficial to use Detergent 8 when cleaning circuit boards and electronic components?

Detergent 8 contains no conductive metal cations, and therefore it cannot leave conductive residues. Its coupling ability keeps soils suspended in the cleaning solution, not on the circuit boards. If the solution is promptly washed away with deionized water, boards will meet the omega-meter or ionograph standards of cleanliness. Detergent 8 can be used in a variety of electronic applications, such as, cleaning glass substrate before dichloric coating of electronic parts, cleaning during manufacturing and assembly, cleaning electronic contacts and leads as well as ceramic insulators and components.

Detergent 8 can be used manually, soak or spray. For more information please visit

For more on cleaning electronics, please visit Alconox website at

Tuesday, December 04, 2007

ar Reactor Cavity and Equipment Decontamination

What cleaner does Alconox recommend for the decontamination of nuclear reactor cavities and related equipment?

Alconox recommends Detergent 8, a non-ionic, phosphate-free homogeneous blend of an alkanolamine, glycol ethers and an alkoxylated fatty alcohol for decontaminating nuclear reactors and related equipment including pipes, tools, and protective equipment. It contains no chelating agents or halides, or conductive metal cations. It is imperative to avoid detergents containing chelating agents as they can bond chemically to radioisotopes. Also it is important to avoid detergents containing fluorides, chlorides, or sulfur ingredients which might cause surface corrosion or intergranular stress corrosion of stainless components.

If the key concern is avoiding waste interference, then Detergent 8 is the brand to use. Detergent 8 can be used manually, soak or spray. For more information please click here.

Use Alconox brand products in the nuclear industry! Visit our website.