Alconox Brands for Ultrasonic Tank Cleaning

Question:
What is ultrasonic tank cleaning? Which industries commonly employ the method? What Alconox, Inc brands would be ideal for ultrasonic tank cleaning?

Answer:
Ultrasonic Tank cleaning works best on objects or part that are made of stainless steel, mild steel, aluminum, copper, brass, other alloys, plastic or rubber. The object to be cleaned is placed in a chamber containing a suitable ultrasound conducting fluid such as an aqueous cleaner depending on the application. Aqueous cleaners typically contain surfactants that reduce the surface tension of the water. An ultrasound generating transducer is built into the chamber, or may be lowered into the fluid. It is electronically activated to produce ultrasonic waves in the fluid. The main mechanism of cleaning action is by energy released from the creation and collapse of microscopic cavitation bubbles, which break up and lift off dirt and contaminants from the surface to be cleaned. The higher the frequency, the smaller the nodes between the cavitation points which allows for more precise cleaning.

Industrial ultrasonic cleaners are used in the automotive, printing, marine, medical instruments, medical device manufacturing, electroplating, and weapons industries.

Liquinox, critical cleaning liquid detergent, is a high emulsifying cleaner that is an excellent product for use in soak and ultrasonic cleaning. Citranox, acid cleaner and detergent, is also a high-emulsifying cleaner ideal for metal oxides and deposits.

Technical Bulletins and MSDS for each are downloadable from www.alconox.com or

• Liquinox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_liquinox.pdf


• Liquinox MSDS: http://www.alconox.com/static/msds/msds_liquinox.asp


• Citranox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_citranox.pdf


• Citranox MSDS: http://www.alconox.com/static/msds/msds_citranox.asp

Alconox Brands for Clean-In-Place (CIP) Systems

Question:
What Alconox brand cleaners are recommended for Clean-In-Place (CIP) systems? What information does Alconox offer to assist in validating CIP cleaners?

Answer:

It is desirable to use a low foaming cleaner that rinses freely in a CIP system. Selecting the appropriate CIP cleaner will be determined by the type of soil being removed as well as the hard surface being cleaned. Alconox, Inc manufacturers' several low foaming liquid cleaners that work well in CIP, including Solujet, an alkaline cleaner, and Citrajet, an acidic cleaner. An alkaline cleaner best removes oils, fats, grease and an acidic cleaner works best to remove insoluble hydroxides and metal oxides. Both Solujet and Citrajet are suitable to use on stainless steel manufacturing surfaces.

• Technical Bulletins and MSDS for each are downloadable from www.alconox.com
  
• Solujet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_solujet.pdf
• Solujet MSDS: http://www.alconox.com/static/msds/msds_solujet.asp
• Citrajet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf
• Citrajet MSDS: http://www.alconox.com/static/msds/msds_citrajet.asp

Alconox, Inc provides assistance to validate cleaners for CIP systems. Information on residue detection methods for Solujet and Citrajet can be found at http://www.alconox.com/static/section_top/gen_cleanval.asp.

Pharma Clean In Place (CIP) and Standard Operating Procedures (SOPs)

Question:
What is clean in place (CIP)? What are four reasons the pharmaceutical industry commonly employs clean in place (CIP) systems? Does Alconox, Inc have information on CIP Standard Operation Procedures (SOPs)?

Answer:
CIP stands for Clean-In-Place and is a method of cleaning the interior surfaces of closed systems and process equipment without dismantling the equipment. There are different types of CIP including, single pass systems and recirculation system.
The pharmaceutical industry heavily relies on clean in place (CIP) system because operators are not required to enter plant to clean, difficult to access areas can be cleaned, production time between production runs is minimized, and recycling the cleaner can reduce cost. Equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Alconox provides support to meet cGMP regulations. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, where Standard Operating Procedures for CIP systems are discussed (see Chapter 7). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.

Alconox, Inc Provides Pharma Cleaning Validation Support

Question:
What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation?

Answer:
Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning process and any microbial contaminants on the surface of the manufacturing equipment or utensil. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.

Alconox, Inc provides validation support to help meet pharmaceutical cGMP requirements. Alconox, Inc Technical Team has written Pharmaceutical Cleaning Validation References that includes a directory of cleaner residue detection methods for each Alconox brand. Also to help comply with cGMP regulations all cleaner brands have traceable lot specific certificate of analysis (COA), Technical Bulletins and MSDS.

Alconox, Inc Support Pharma Manufacturers with CFR-Part 211.67

Question:
What is 21 CFR-Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?

Answer:
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance. For more details visit, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67.

The Alconox technical support team has developed a guide for cleaning validation to help the pharmaceutical manufacturer meet these standards. The cleaning validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues three or more times and then establish a rational monitoring program that verifies that the validated state is being maintained. For more information please visit the Alconox website at www.alconox.com/static/section_top/gen_cleanval.asp.

MD&M East 2008, Alconox Booth #2266

Question:
Will Alconox, Inc attend the MD&M East Show in 2008?

Answer:
Alconox, Inc will be attending the MD&M East Show at the Jacob Javits Center New York City, NY on June 3-5. Stop by our booth #2266 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook!

You'll want to visit Alconox, Inc booth #2266 at MD&M EAST because...

Alconox, Inc is The Leader in Critical Cleaning Detergents with sixty years of experience getting medical equipment critically clean for use in demanding human or veterinary health applications, and in the manufacturing of medical devices - such as titanium prosthetic hip joints - we understand how to clean to implantable standards. Whether the product is designed for in vitro or in vivo use, is biomechanical or electronic, you'll find an Alconox cleaner expressly formulated to get products scrupulously clean without leaving interfering residues.

You'll meet the Alconox, Inc technical experts who are ready to discuss your cleaning validation needs!

MD&M is the recognized resource since 1983 for everything you need to design and manufacture medical devices and equipment for today's increasingly competitive healthcare marketplace. For more information please visit this website: http://www.devicelink.com/expo/east07/.

Interphex2008, Alconox Booth #107

Question:
Will Alconox, Inc attend the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition?

Answer:
Alconox, Inc will be attending the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition at the Pennsylvania Convention Center - Philadelphia, PA March 26-28, 2008. Stop by our booth #107 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook! Great opportunity to "Ask Alconox" and get experts advice about your industrial cleaning needs! Mark your calendars for INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition!

INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market - accelerating regulated products for patient care globally.

INTERPHEX is the only Life Sciences event that represents a true cross-section of the pharmaceutical and biopharmaceutical industries. Industry-leading professionals worldwide make INTERPHEX the industry's annual focal point for driving change and efficiencies for the global pharmaceutical and biopharmaceutical market.
INTERPHEX will once again feature the co-location of PharmaMedDevice, the only comprehensive event to focus on the convergence of medical device, pharmaceutical, and biologic industries.

For more information about INTERPHEX, please click here.