Tag Archive | "cleaning validation"

Visual Inspection

Cleaning Visual Inspection

Q: I work for a medical device company where we make machined parts. I’m interested in finding a supplemental visual inspection tool that will aid in inspecting the surface of a part after being cleaned. A: We would recommend getting…..

Read the full story

Posted in Manual Lab Cleaning, Medical Device, PharmaceuticalComments (0)

Biocompatibility Testing for Pyrogens

Your detergents have corresponding biocompatibility data. Our medical devices must be pyrogen and endotoxin free. Someone mentioned that biocompatibility tested detergents, like yours, will be free of organic residues like endotoxins and pyrogens. Is this true?

Read the full story

Posted in Biotechnology, Medical Device, PharmaceuticalComments (0)

What is Critical Cleaning?

Q: What precisely is critical cleaning? How does it differ from “regular” cleaning? A: It refers to a very specific type of cleaning. It is where the cleaning itself impacts the value of the finished output from whatever residue/contaminant is being cleaned.

Read the full story

Posted in Aerospace, Biotechnology, Cosmetic, Electronic, Environmental, Filter, Food & Beverage, Foodservice, Healthcare, Industry, Laboratory, Manual Lab Cleaning, Medical Device, Metalworking & Precision Manufacturing, PharmaceuticalComments (0)

Influences on Pharmaceutical Cleaning Validation

Alconox Inc.’s Director of Technical Marketing and Commercial Development, Michael Moussourakis, sat down at the Oral Solid Dosage Symposium 2017 with Pharma’s Almanac TV’s, Mark Allen, to discuss how globalization is influencing the latest trends on cleaning validation. Click here to watch the video and hear how the growing market for CDMO Cleaning Validation training, and the opportunities in cleaning non-critical single use technology.

Read the full story

Posted in Validation, VideoComments (0)

Detecting Residue in Cleaning Validation

When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation service support

Read the full story

Posted in Articles, Cosmetic, Medical Device, Pharmaceutical, ValidationComments (0)


One Detergent to Clean Them All?

Q: We are advising a mid-sized pharmaceutical company. If we use multiple cleaning agents within a facility, the cleaning program may be a bit difficult to manage (chances are that the operators may use the incorrect cleaning agent for the product) and also the cleaning validation will be a more complex exercise. What would you recommend for general cleaning? Which is preferred between acidic and alkaline cleaning agent to start with?

A: Thank you for your inquiry for a multi use detergent as this is certainly not an uncommon question. Learn more….

Read the full story

Posted in Biotechnology, Detergents, Laboratory, PharmaceuticalComments (0)

Determining Acceptable Residue Limits

Q. How do you determine acceptable residue limits when performing a cleaning validation?

A. All Alconox Inc. cleaners have an oral LD50 of greater than 500 mg/Kg acceptable residue limit. Alconox®, Liquinox® and Citranox® all have an oral LD50 of greater than 5 g/Kg. If you calculate 1/1000 of the LD50 as a potential residue in a dose …

Read the full story

Posted in Alconox, Citranox, Detergents, Liquinox, Medical Device, PharmaceuticalComments (0)

Medical Device Cleaning Validation Consultant

Q. Does Alconox, Inc. offer validation consultants to provide validation tech support?
A. Alconox, Inc. provides support for regulatory-compliant cleaning validations which includes lot number traceability of all cleaners and ingredients, cleaner toxicity and reactivity/degradation information, shelf-life testing, residue sampling, detection methods and written cleaning procedures.

Read the full story

Posted in Medical Device, ValidationComments (0)

What is Pharmaceutical Cleaning Validation?

What is Pharmaceutical Cleaning Validation?

Alconox answers the question; “What is pharmaceutical cleaning validation”? Learn more about compliance with cGMP regulations for all Alconox cleaner brands

Read the full story

Posted in Cosmetic, PharmaceuticalComments (0)