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Cleaning Validation – Scienti c method

Explore publications, projects, and techniques in Cleaning Validation, and nd questions and answers from Cleaning Validation
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All research related to Cleaning Validation

Kalyan Sonti
answered a question related to Cleaning Validation
Is it mandatory to check degradation residue during cleaning validation. If so how to de ne limit and how is it going to impact hold time
study?
Question 6 Answers
Kalyan Sonti
If so how to de ne limit for routine cleaning validation studies. How is it going to impact hold time study as each product has it's own
impurities but in general only one worst case molecule is considered for study
Kalyan Sonti
“Ms. Ani thanks for your reply. I would like to ask you how do you calculate 3 log reduction for degradant?. Can you please explain in
detail as I am unaware of it”
View
Dean Calhoun
Dear fellow scientists, can anyone provide me with a free database for ADE/PDE values for cleaning validation?
Question 1 Answer
Jean Charles Ghazi Sarraf
I am interested in nding values for: 1- Losartan Potassium 2- Hydrochlorothiazide 3- Dequalinium Chloride 4- Lidocaine hydrochloride 5-
Desloratadine 6- Betametasone
Dean Calhoun
“Haha! Good luck with that one. There is no free database. Occupational toxicologists are rare. They are not going to give away their
expertise for free. We have expert written monographs for all the compounds you mentioned above. Go to https://goo.gl/dGrSqo to
view our entire catalog.”
View
Ani Amar
Which is the best method for sampling Mycoplasma from equipments and facilities?
Question 3 Answers
Luis Felipe Buso Bortolotto
Hi, researchers. I'll test a PCR-based method for detection of Mycoplasma hyopneumoniae in samples collected from benches and
equipments (bioreactor and centrifuge). However, I need help to know which sampling technique is most appropriate. Should I swab these
surfaces? How? Can anyone suggest what needs to be done in order to get representative samples? Thanks!
Ani Amar
“Hi. I am not familiar with this Mycoplasma "friend". But you can perform: 1. Total viable count (for example rinse sample). Then,
ltration, incubation and identi cation. I also recommend you to give few time points for incubation (e.g., 72 hr, to check it, and then
t ti if l t( k it d d thi " f i d" i diti ) 2 B t l d LAL ( d t i ) F
https://www.researchgate.net/topic/Cleaning-Validation 1/13
to continue if relevant (e.g., week= it depends on this "myco-friend" speci c conditions). 2. But also you need LAL (endotoxins). For
swabs, you need to justify worst case locations in your equipment. I recommend you sterile COPAN swabs. I understood that you
know how to identify "myco-friend" colonies. Otherwise i missed...” more
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Logeshwaran Sivasubramanian
In calculating Permitted Daily Exposure (PDE), can anyone explain about adjustment factor especially F4?
Question 3 Answers
Nyoman yoga Irwan
In calculating Permitted Daily Exposure (PDE) about cleaning validation, can anyone explain about adjustment factor especially F4? F4 about a
factor that may be applied in cases of severe toxicity. Value of F4 1 = for fetal toxicity associated with maternal toxicity 5 = for fetal toxicity
without maternal toxicity 5 = for a teratogenic effect with maternal toxicity 10 = for a teratogenic effect without maternal toxicity can anyone
explain to me why teratogenic effect without material toxicity got a higher point than teratogenic effect with material toxicity?
Logeshwaran Sivasubramanian
“I have provided my justi cations below, 1. In simple concept, a factor of 10 is the most conservative factor that you can chose in
case of severe toxicity. Eventually, when you notice teratogenic effect at a dose, and you consider a factor of 10 for that even if it has
no maternal t, your factor of 10 covers up all possible considerations for toxicity which includes fetal, maternal and developmental
toxicity. This is the reason why a factor of 10 is provided for a teratogenic effect alone without maternal toxicity. 2. A factor of 10
shall be used only in case of effects seen in a LOAEL. An NOAEL is provided only when there are no drug related effects seen. And
hence, under NOAEL when you consider either a factor of 5 or 10, you cover all possible effects of the drug on basis of
conservatism. In my opinion, when there are no effects reported at all or an NOEL is given I use a F4 of 1 to calculate PDE. Only in
LOAEL we consider 10. Hope this is clarifying. But the factor consideration for PDE calculation is always a debatable topic. But one
idea is very clear when there are no effects seen at a dose, lesser factor considerations (3 and less) should not cause any
considerations.” less
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Kapil Patil
asked a question related to Cleaning Validation
In case ve compression machine diffrant designing but same principle how to selected worst case machine in cleaning validation ??
Question 0 Answers
Kapil Patil
in case ve compression machine diffrant designing but same principle how to selected worst case machine in cleaning validation ??
View
Md. Mehdi Hasan
What is formula for MACO calculation in cleaning validation of manufacturing tank used for parenteral product and what is acceptance
limit?
Question 0 Answers
Md. Mehdi Hasan
What is formula for MACO calculation in cleaning validation of manufacturing tank used for parenteral product and what is acceptance limit?
View
Bruce Neagle
Can anyone provide me a cleaning validation protocol?
Question 1 Answer
Md. Abdul Bake
Cleaning validation protocol is needed for uid bed dryer.
Bruce Neagle
“Any cleaning validation protocol is used to evaluate your cleaning procedure. It is unique because the cleaning procedure is unique
as well as the equipment ( uid bed dryer in this case) and the manufacturing process. As as yardstick I would use the 'acceptable
daily exposure' (ADE) of the most toxic molecule you make or the hardest to clean formulation (if a dietary supplement).”
View
Abu Siddique
For cleaning validation purposes, PDE value of Tenoxicam is required.To calculate, what will be the value of F1, F2, F3, F4 & F5 for
Tenoxicam?
Question 0 Answers
b dd
Abu Siddique
For cleaning validation purposes, PDE value of Tenoxicam is required. The calculation formula is PDE = (NOAEL x Weight Adjustment) / (F1 x
F2 x F3 x F4 x F5). To calculate the PDE value, what will be the value of F1, F2, F3, F4 & F5 for Tenoxicam?
View
Michael Crisanti
How to use HPLC with column C18 to determine quantity of Teepol residue after cleaning?
Question 3 Answers
Suman Chanyoung
Hello, Now, I'm working in the process of cleaning validation. I want to detect Teepol by using HPLC with C18 because there are in my factory.
If I use that equipments, I will save cost of spending for new column. But, I have found that many researchers use speci c column to detect
Teepol. So, I want an idea about using HPLC with column C18 to determine quantity of Teepol residue after cleaning. However, If anyone has
the other method to detect Teepol, please feel free to tech me. Thank you
Michael Crisanti
“I'm not familiar with Teepol, but based on the MSDS I found online it looks like it's a mixture of two anionic surfactants
(alkylbenzene sulfonate and alkyl ether sulfate) and one nonionic surfactant (alcohol ethoxylate). When using a C18 column
(reversed phase) you're separating these compounds by their akyl chains and unfortunately their alkyl chains are all similar. So, you
will need a long gradient and a lot of theoretical plates. That being said, it's still hard to separate the two anionic surfactants. They
still tend to elute together. Try going from 10% organic to 90% organic over...” more
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Rishabh Srivastava
What factors are to be considered for validation of a cleaning method?
Question 10 Answers
Rishabh Srivastava
Cleaning validation, QMS, Quality assurance
Rishabh Srivastava
“In pharmaceutical industry we need to be sure that traces of previous products don't contaminate the next products. Thus we have
to perform the cleaning validation to be sure that even invisible particles were removed for the product that is more prone to
microbial contamination, insoluble or very hard to clean. ”
View
Hozefa Karodiya
Can anyone explain cleaning validation?
Question 3 Answers
Hozefa Karodiya
Anyone who is working in validation or has good knowledge of cleaning validation, please explain the whole concept and if you have any le
regarding this topic please share it with me.
Hozefa Karodiya
“Its related to manufacturing process.. ”
View
Andrew Walsh
added an Article related to Cleaning Validation
Measuring Risk In Cleaning : Cleaning FMEAs And The Cleaning Risk Dashboard
Article Apr 2018
Andrew Walsh · Thomas Altmann · Alfredo ; Canhoto · Kelly Waldron
This article discusses the concept and measurement of risk as it applies to the cleaning of pharmaceutical products. Four previous articles
discussed how science-based data-derived scales could be created using compound HBELs (health-based exposure limits), from the process
capability (Cpu) of the products’ cleaning processes and from the detection limits for visual inspection or for total organic carbon (TOC)…
View 911 Reads
Petr Zamostny
created a project related to Cleaning Validation
Pharmaceutical Process Cleaning Validation
Project
Project
Petr Zamostny · Jan Patera · Kateřina Punčochová
Read 0 Updates
Imeda Rubashvili
Validation of sampling procedures and quantitative determination HPLC method of Alprazolam residues for cleaning validation
Article Jun 2018
Imeda Rubashvili
View
Md. Abdul Bake
Cleaning Validation Sample Protocol
Article Jan 2013
Md. Abdul Bake
View 5,988 Reads

Biunayki Reyes
Cleaning Validation automatic lling machine
Project
Biunayki Reyes · Denis Alvarez · Luciano Hernández
Goal: The media ll equipment we use for automatic lling of Petri dishes with culture medium, for environmental microbiological control,
according to the manufacturer's method sanitization is through cleaning in place by heat, and manually using detergent, does not specify that
detergent what we want to use the sanitizers we use daily in cleanroom sanitization Grade a and Grade B. I would like to hear views on that
higienizante out the most recommended for sanitizing equipment without affecting lling me with culture medium plates.
Read 0 Updates
Karoline Bechtold-Peters
added a Chapter related to Cleaning Validation
Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug
Product
Chapter Jun 2018
Karoline Bechtold-Peters · Silke Mohl
The manufacturing of highly potent drug products in a multi-product aseptic facility and the transfer of principles to antibiotic drug products is
certainly a challenging eld. The authors have successfully implemented this in a clinical manufacturing unit and have been able to explain the
rationales to regulating authorities. The assumption of a physically imaginable worst-case approach considering various risk-reducing factor…
View
Sakthivel Lakshmana Prabu
cleaning validation and its importance in pharmaceutical industry
Article Jul 2010
Sakthivel Lakshmana Prabu · TNK Suriya Prakash
Pharmaceutical Manufacturers must validate their cleaning process to ensure complies with cGMP regulations. Minimizing equipment
downtime has the potential to impact the ef ciency and economics of pharmaceutical production. The main purpose of cleaning validation is
to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and…
View 5,679 Reads

Andrew Walsh
Cleaning Validation for the 21st Century
Project
Andrew Walsh
Goal: This project is a collection of the articles published to support the movement to a Science-based, Risk-based and Statistics-based
approach for Cleaning Processes and their Validation as outlined in the ASTM E3106-17 "Standard Guide for Cleaning Process Development
and Validation". The collection also includes the publications from the Center for Pharmaceutical Cleaning Innovation, the research and
education arm of the ASTM Standard Guide.
Read 0 Updates
Govind Rajpal
A review on cleaning validation in pharmaceutical industry G Raj Pal, RKK Arya, T Joshi, D Bisht Journal of Drug Delivery and Therapeutics 8
(3), 138-146
Article Jun 2018
Govind Rajpal
View 3 Reads
A d W l h
Andrew Walsh
Microbial Aspects in Cleaning Validation
Chapter Feb 2011
Andrew Walsh
This chapter will discuss microbiology as it pertains to Cleaning Validation. In practice, the primary focus of Cleaning Validation is the removal
of chemical residues, either from active ingredients or cleaning agents, and microbiological issues are of an incidental nature. It should be
understood that the purpose of cleaning procedures should never be seen as being used to reduce microbial residues to acceptable levels.
View 4,213 Reads

Paul Lopolito
Cleaning validation of automated parts washer
Project
Paul Lopolito
Read 0 Updates
Enrico Fuchs
added a Conference Paper related to Cleaning Validation
In uence of the nozzle distance on the cleaning result compared to the jet break up and the mechanical forces on an industrial scale
Conference Paper Apr 2018
Enrico Fuchs · Sebastian Kricke · Enrico Schöhl · Jens-Peter Majschak
This paper presents the in uence of the standoff distance L = 0.5…5.0 m of a stationary full jet nozzle (dN = 3 mm) on the cleaning effect.
Two nozzle pressures pN = 2.0 bar, 4.0 bar (ReJet = 42187…60191), and four different soiling types with signi cantly different cleaning
behaviour were investigated (petroleum jelly, ketchup, mustard, starch + diatomaceous earth). The results show that for a long time scale th…
View 7 Reads
Andrew Walsh
added a Code related to Cleaning Validation
Spreadsheet to Create a Toxicity Scale from HBELs
Code Apr 2018
Andrew Walsh · Mohammad Ovais
This spreadsheet can create Toxicity Scales from HBEL data which can be used to create a Cleaning Risk Dashboard
View 217 Reads

Mohammad Ovais
Data-derived recovery factors for cleaning validation studies
Project
Mohammad Ovais
Goal: The current approaches of setting recovery factors are vague and not statistically justi able. Through this work I will highlight the
problem with the current approaches and propose methods of setting recovery factors that are statistically justi able and data-derived.
Read 0 Updates
Matteo Federici
added a Poster related to Cleaning Validation
Media- ll simulation tests of infusion bags prepared in series by the compounding robot APOTECAchemo
Poster Mar 2018
Matteo Federici · Irene Krämer
View 7 Reads
T. Kaminagayoshi
The statistical evaluation of cleaning processes using process capability and its application to new product introduction
Article May 2018 · Pharmaceutical Technology
T. Kaminagayoshi · K. Takenaka · T. Doi · A. Walsh
At rst, the capability of cleaning process was evaluated for an antibody drug manufacturing facility using the Cpu, which is one of the
common methods to evaluate the process capability in quality engineering. Consequently, the authors succeeded in evaluating the capability
of the cleaning processes for all equipment used in the actual production by classifying the equipment into groups. The study demonstrated…
View 528 Reads

Piyush Sharma
Tissue Harvesting for Heart Valves
Project
Piyush Sharma
Goal: I am working in medical device company which manufacture heart valves. I am working as a Quality Engineer. I look after GMP in
Manufacturing process Currently working on Cleaning Validation and Chemical sterilization
Manufacturing process. Currently working on Cleaning Validation and Chemical sterilization.
Read 0 Updates
M Alami Chentou
5PSQ-072 Tolerance pro le of platinum salts in anticancer chemotherapy: a prospective study
Conference Paper Mar 2018
M Alami Chentou · M Benabbes · S Bennis · B Meddah
Background Cisplatin, carboplatin and oxaliplatin are three major platinum salts used for intravenous chemotherapy. However, their ef cacy is
accompanied by different toxicities. Purpose The aim of our study is to identify adverse drug reactions of platimum salts. Material and
methods An observational prospective analysis was conducted between March 2014 and September 2015 in the oncology sector of a centr…
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Andrew Walsh
An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
Article May 2017
Andrew Walsh · Ester Lovsin Barle · Michel Crevoisier · Kelly Waldron
This article discusses how to derive a Toxicity Scale from the ADE (with scores form 1-10) and how the ADE of any compound can be directly
converted into a score on this scale. This Toxicity Scale can be used to quickly assess the potential for the risk of cross contamination in
manufacturing situations through an easy to use visual scale. This Toxicity Scale can be used as the "Severity" Score in FMEAs of Cleaning…
View 1,205 Reads

Bujji Reddy Kanchi
Docosonal cleaning validation by UV Spectroscopy
Project
Bujji Reddy Kanchi
Goal: cleaning (Rinse and swab ) samples test by using UV spectroscopy method development
Read 1 Update
N Ott
3PC-037 Cleaning validation of solution production in a hospital pharmacy
Conference Paper Mar 2018
N Ott · U Lösch · S Deuster
Background Cleaning of technical equipment should remove residues of products and cleaning agents, as well as avoid microbial
contamination.¹ In hospital pharmacies multipurpose equipment is used for the manufacture of different pharmaceutical preparations.
Suitable well-documented cleaning procedures are necessary to guarantee patient safety by avoiding cross-contamination of drugs. Purpos…
View 3 Reads
L. Carlyle
‘Triammonium citrate: an investigation into its application for surface cleaning’
Article Jan 1990
L. Carlyle · J.H. Townsend · S. Hackney
View 807 Reads

Govind Rajpal
A review on cleaning validation in pharmaceutical industry
Project
Govind Rajpal
Read 0 Updates
Enrico Fuchs
added a Data related to Cleaning Validation
Link
Data Feb 2018
Enrico Fuchs · André Boye · Hannes Stoye · Marc Mauermann
View
Andrew Walsh
Spreadsheet for create Detectability Scales from TOC and Visual Inspection Detection Limits
Code Apr 2018
This spreadsheet can create Detectability Scales from both TOC and Visual Inspection Detection Limits which can be used for creating
Cl i Ri k D hb d
Cleaning Risk Dashboards
View 665 Reads

A researcher
Cleaning Validation
Project
Goal: Produce all documentation
Read 0 Updates
Roman Murcek
Link
Data Feb 2018
Roman Murcek · Enrico Fuchs · André Boye · Jens-Peter Majschak
View 2 Reads
Thomas Altmann
Developing A Science-, Risk-, & Statistics-Based Approach To Cleaning Process Development & Validation
Article Jun 2017
Thomas Altmann · Alfredo Canhoto · Michel Crevoisier · Andrew Walsh
This article reviews the need for changes to cleaning validation from the traditional compliance-based approaches to Science, Risk and
Statistics-based approaches and the regulatory initiatives driving this change.
View 389 Reads

Alaa Khaled Al-Jayeh
Cleaning validation
Project
Alaa Khaled Al-Jayeh
Goal: to claculate the cleaning validation limit for detergent used in cleaning semi solid line
Read 0 Updates
Ani Amar
S1 Table
Data Jan 2018
Ani Amar · Sharon Zlochiver · Ofer Barnea
Electrophysiological modi cations in HF. (DOCX)
View
Andrew Walsh
An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
Article Dec 2017
Andrew Walsh · Thomas Altmann · Alfredo Canhoto · Kelly Waldron
Two previous articles discussed how the acceptable daily exposure (ADE) of a compound and the process capability (Cpu) of its cleaning
process can be used to assess the level of risk associated with cross contamination in shared facilities. This article will discuss how the
maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection f…
View 1,347 Reads

Thomas Brauge
S1 Fig
Data Jan 2018
Thomas Brauge · Christine Faille · Irina Sadovskaya · Graziella Midelet-Bourdin
Dendrogram of obtained using ApaI and AscI enzymes demonstrating the genetic diversity of L. monocytogenes isolates. (PDF)
View 1 Read
Andrew Walsh
A Swab Limit-Derived Scale For Assessing The Detectability Of Total Organic Carbon Analysis
Article Jan 2018
Andrew Walsh · Thomas Altmann · Alfredo Canhoto · Kelly Waldron
This article discusses how the detection limit for analytical methods can be combined with cleaning validation swab limits to create a
detectability scale similar to that described in our earlier article on visual inspection. This new detectability scale can assist in determining
whether an analytical method is acceptable for use in a cleaning validation or veri cation Combined with the HBELderived toxicity scale and
whether an analytical method is acceptable for use in a cleaning validation or veri cation. Combined with the HBELderived toxicity scale and…
View 670 Reads

Thomas Brauge
S1 Table
Data Jan 2018
Accession numbers of any nucleotide sequence data. (PDF)
View 1 Read
Andrew Walsh
Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
Article Nov 2013 · Pharmaceutical Engineering
Andrew Walsh · Mohammad Ovais · Thomas Altmann · Edward V Sargent
This article presents currently suggested approaches to setting acceptance limits for cleaning agents, some of the dif culties with these
approaches, emphasizing the need to move to a health-based approach as was suggested for APIs. Two previous articles in this series
discussed acceptance limits for Active Pharmaceutical ingredients (APIs) and moving to a health-based approach. This article will discuss t…
View 3,392 Reads

Thomas Brauge
S2 Fig
Data Jan 2018
Growth of the wild-type EGD-e strain, DSS 1130 BFA2, EGD-eΔlmo2549 and EGD-eΔlmo2550 mutants and the complemented mutants EGD-e
Δlmo2549:: pLIV2(lmo2549) and EGD-e Δlmo2550:: pLIV2(lmo2550) at 30°C in MCDB202 medium during 48 h. (PDF)
View 2 Reads
Zahid Zaheer
Analytical Methods for Cleaning Validation,
Article Jan 2011 · Der Pharmacia Lettre
Zahid Zaheer · Rana Zainuddin
Residue identi cation in a pharmaceutical manufacturing environment involves; the cleaner, primary ingredients, excipients, decomposition
products, and preservatives. This document is intended to help with the cleaner residue identi cation. Residue detection method selection for
cleaners can involve speci c methods for speci c cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selectiv…
View 2,282 Reads

Davor Korcok
Low moisture starch for improved viability and stability of new Probiotic L. plantarum 299v preparation
Article Jan 2018 · Hemijska industrija
Davor Korcok · Olivera Colic · Nada Trsic-Milanovic · Bogdan Mitic
Probiotic pharmaceutical preparations are more and more popular because of the increasing level of evidence of their bene cial effect on
human health. The goal of this study was to determine and develop the encapsulated probiotic formulation with the optimal lling amount of
active ingredient - Lactobacillus plantarum that would, in combination with other active ingredients: iron, vitamin C and excipient starch, ful l…
View 11 Reads
Andrew Walsh
Cleaning Validation for the 21 Century: Overview of New ISPE Cleaning Guide
Article Nov 2011
Andrew Walsh
This article provides an overview of an ISPE Cleaning Guide that was formerly under development from 2007 to 2015. ISPE decided not to
publish it in 2015 and it was subsequently published by ASTM as E3106-17 "Standard Guide for Science and Risk-Based Cleaning Process
Development and Validation" The Guide will provide a framework for a scienti c, risk-based approach to cleaning processes and validation.…
View 1,496 Reads

Dina Louis
Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up
Article Dec 2017 · Acta Pharmaceutica
Dina Louis · Aliaa A. Badawi · Mahmoud M. Hegazy · Mohammed A. Eldegwy
L-carnitine-L-tartrate, a non-essential amino acid, is hygroscopic. This causes a problem in tablet production due to pronounced adhesion of
tablets to punches. A 33 full factorial design was adopted to suggest a tablet formulation. Three adsorbents were suggested (Aerosil 200,
Aerosil R972, talc) to reduce stickiness at three concentrations (1, 3 and 5 %), and three llers (mannitol, Avicel PH 101, Dibasic calcium…
View 123 Reads

View 123 Reads
Steven Richter
Cleaning Validation of medical products
Chapter May 2015
Steven Richter
Cleaning of Medical Devices is written to describe the points to consider when setting up a cleaning protocol required under the FDA
reprocessing guidelines
View 1,772 Reads

Bruno Manuel Ribeiro Alves
added a Preprint related to Cleaning Validation
Estado da arte de modelos viscoelásticos
Preprint Dec 2017
Os materiais poliméricos possuem uma estrutura complexa, que frequentemente origina comportamentos difíceis de antecipar, por vezes
contra-intutitivos, como são os casos: da diferença de tensões normais não nulas, do efeito de Weissenberg, do inchamento e da retração
elástica. Ao longo do tempo foram propostos diversos modelos para o comportamento destes materiais, que têm por objetivo permitir prev…
View 12 Reads
Andrew Walsh
Cleaning Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs) - Part II
Article Sep 2011
Andrew Walsh
This article discusses how to establish true science-based limits using data from clinical and toxicological studies, a risk-based approach to
evaluating cleaning validation data, and guidance on setting statistical process control limits from that data. Introduction Part I of this article 1
discussed the history of Cleaning Validation Acceptance Limits for Active Pharmaceutical Ingredients and where the currently used industry…
View 1,383 Reads

X. Shan-Shan
Application of total organic carbon method in cleaning validation during production of acellular pertussis vaccine
Article Nov 2017 · Chinese Journal of Biologicals
X. Shan-Shan · L. Dan · Y. Yong · Z. Rong-Li
Objective To prove that the total organic carbon (TOC) method may be applied to cleaning validation during production of acellular pertussis
(aP) vaccine, and evaluate the effectiveness of the cleaning methods. Methods TOC method was veri ed for linearity, precision (reproducibility
and intermediate precision), accuracy,limit of detection (LOD), limit of quantitation (LOQ) and robustness. Recovery rate on the surface of…
View 4 Reads
Andrew Walsh
Are high potency active pharmaceutical ingredients (HPAPI) also high risks for cross-contamination?
Article Dec 2017 · Chimica oggi
Andrew Walsh · ester lovsin-barle
The terms highly hazardous, highly active and highly potent are often used in mixed or inconsistent contexts regarding good manufacturing
practice and worker safety. This article provides an overview of de nitions and criteria used for classifying active pharmaceutical ingredients
(APIs) and the use of these terms for identi cation of risks in cleaning validation. While competent toxicological evaluation is required to…
View 1,253 Reads

Tareq Abdhilkadim Alasadi
Cleaning technology of drugs
Data Nov 2017
Tareq Abdhilkadim Alasadi
Cleaning in Finished, Biopharmaceuticals, and Bulk Chemicals Finished pharmaceuticals exist in a broad range of dosage forms, which include
solid, semisolid, liquid, aerosols, and parenteral formulations. Often a large number of product types of several different strengths are
manufactured in one facility. This necessitates the use of special precautions to prevent product-to-product carryover. One of the strategies…
View 32 Reads
Andrew Walsh
Spreadsheet to Create a Process Capability Scale from Cpu Data
Code Apr 2018
This spreadsheet can create a Process Capability Scale from Cpu data which can be used for creating a Cleaning Risk Dashboard
View 182 Reads

Paul Lopolito
Paul Lopolito
Evaluating surface cleanliness using a risk-based approach
Article Nov 2017 · Biopharm International
Paul Lopolito · Elizabeth Rivera
Regulated companies that use automated cleaning applications have always struggled with correlating rinse sample quality or visual
inspection to surface cleanliness. The process typically involves performing 100% spray coverage testing, rinse recovery testing, speci c or
non-speci c analytical method quali cation, surface sampling and recovery testing of the sampling technique, and visual inspection…
View 14 Reads
Andrew Walsh
Why the 10-ppm and 0.001-Dose Criteria Should be Abandoned, Part II
Article Aug 2016 · Pharmaceutical Technology
Andrew Walsh · michel creviosier · Ester Lovsin Barle · Mohammad Ovais
This article discusses how the 10ppm limit, along with the 0.001 dose limit, are not truly risk-based approaches and are also unsound from an
operational standpoint as they have caused unnecessary dif culties for many companies. A statistical process-based approach to
demonstrate that acceptable cleaning has been achieved compared to a health-based limit is proposed.
View 1,826 Reads

Koos Agricola
Methods to keep a product clean
Article Oct 2017
Koos Agricola
Contamination control concerns methods to keep a product clean. For this reason the cleanliness of the surface of a product is expressed in
terms of particles and also chemicals. Products can be contaminated by deposition or contact transfer. Deposition depends on the
concentration of particles in the air and their deposition velocity. Large particles have a high deposition velocity and their concentration…
View 14 Reads
Mohammad Ovais
On Cleaning Validation Recovery Studies: Common Misconceptions
Article Jun 2017
Mohammad Ovais
The reliability of cleaning validation results depends on the validity of sampling procedures used. In order to ensure that the sampling
procedures are suitable for their intended purpose, these procedures are quali ed under simulated laboratory conditions, using
recovery/spiking studies. Unfortunately, there are a number of misconceptions about recovery studies that could potentially result in incorre…
View 1,213 Reads

Modeling Ziegler-Natta catalyzed LLDPE with FOV technique
Article Sep 2017
The present work is based on the capacity of modeling experimental data of LLDPE with Ziegler – Natta catalysts with standard FOV uid in
1D. The purpose of the work is to check about the behavior of LLDPE under ow (were performed static experiments and SAOS experiments).
It is seen good adjustments results for G(t), J(t) and dynamic oscillatory experiments. Also, results obey to thermodynamic restrictions…
View 38 Reads
Rajeshwar Kamal kant Arya
A REVIEW ON CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY
Article May 2018
Rajeshwar Kamal kant Arya · Govind Rajpal · Tanuj Joshi · Dheeraj Bisht
In pharmaceutical industry there are some possibilities of contamination and cross contamination because of improper cleaning of
equipment, apparatus, processing area or the starting material, this can lead to severe hazards, therefore in pharmaceutical industry we can’t
afford any contamination as well as cross contamination. This can be minimized by proper cleaning of equipment, apparatus as well as the…
View 39 Reads
Modelling Two Different Disperse Polystyrene with Maxwell Fractional Model in SAOS Experiments
Article Sep 2017
The purpose of this work is to perform two adjustments of different disperse polystyrene using the technique of Alves (Alves, 2017) with the
data present on Farias (Farias, 2009), data belonging to a group of eminent researchers. It is seen that the adjustments are of good quality for
a polystyrene anionic polymerised and with an inferior quality for a free-radical polymerised polystyrene. It leads to a possible correlation wit…
View 21 Reads
View 21 Reads
Parth Desai
Validation Of Visual Inspection As An Analytical Method For Cleaning Validation
Article Sep 2017
Parth Desai · Andrew Walsh
Part of the Cleaning Validation for the 21st Century series U.S. Regulation 21 CFR 211.67 (b) (6) has required the "inspection of manufacturing
equipment immediately before use" since 1979. In practice, pharmaceutical manufacturers have been releasing equipment based on a " visual"
inspection for many years. Subsequently, the industry and even regulators have come to see this "inspection" as a "visual inspection"…
View 864 Reads

M. Crevoisier
Cleaning validation for APIs
Article Sep 2017 · Pharmaceutical Technology
M. Crevoisier · T. Peglow
The industry needs a single standard cleaning limit at 25 mg/m².
View 14 Reads
M. Crevoisier
Cleaning limits-why the 10-ppm criterion should be abandoned
Article Jan 2016
M. Crevoisier · E.L. Barle · A. Flueckiger · A. Walsh
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into to the next
product has been employed for many years. It is, however, arbitrary and does not take into account advances in toxicological risk-Assessment
methodologies that allow for robust and scienti cally supportable approaches to establish safe or acceptable levels of a drug from one…
View 1,452 Reads

C. Malzone
Creating a seamless hydrographic work ow
Article Sep 2017 · Sea Technology
C. Malzone
QPS has evolved the hydrographic work ow to provide a dynamic, multidimensional user interface that allows those even with a low
knowledge threshold to make good decisions that lead to high-end nal products. Users may either utilize QINSy to provide real-time
computations to reduce post-processing to simple cleaning and validation or pair existing acquisition solutions with the guided work ow in…
View 5 Reads
Aliaa A. Badawi
Studies on cleaning validation for a cream and ointment manufacturing line
Article Dec 2016 · Tropical Journal of Pharmaceutical Research
Aliaa A. Badawi · Khaled Hegazy · Dina Louis
Purpose: To validate a new and simple method for cleaning a manufacturing line for creams and ointments. Methods: The worst case product
of the line chosen was a cream containing three practically insoluble ingredients: betamethasone, tolnaftate and cliquinol. The cleaning
method utilized hot water and a commercial detergent, followed by rinsing. Validation methods included the visual inspection of the machin…
View 91 Reads
Imad A Haidar Ahmad
Failure of Cleaning Veri cation in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
Article Aug 2017 · Journal of Visualized Experiments
Imad A Haidar Ahmad · Andrei Blasko
The aim of this work is to identify the parameters that affect the recovery of pharmaceutical residues from the surface of stainless steel
coupons. A series of factors were assessed, including drug product spike levels, spiking procedure, drug-excipient ratios, analyst-to-analyst
variability, intraday variability, and cleaning procedure of the coupons. The lack of a well-de ned procedure that consistently cleaned the…
View 95 Reads
Victoria Pillay-Van Wyk
added a Technical Report related to Cleaning Validation
Second South African National Burden of Disease Study: Data cleaning, validation and SA NBD List
Technical Report Jun 2014
Victoria Pillay-Van Wyk · Ria Laubscher · William Msemburi · Debbie Bradshaw
View 687 Reads

Enrico Fuchs
Erhöhung der Reinigungsef zienz bei der Cleaning-in-Place-Reinigung durch diskontinuierliche Flüssigkeitsstrahlen
g g g g g g g
Article Jul 2017 · Chemie Ingenieur Technik
Enrico Fuchs · Manuel Helbig · Marius P ster · Jens-Peter Majschak
de Hohe Kosten für die Reinigung von Maschinen und Anlagen führen zu Bestrebungen, diese hinsichtlich Reinigungszeit und ‐
üssigkeitseinsatz zu optimieren. Ein Ansatz ist die Anwendung diskontinuierlicher Flüssigkeitsstrahlen. Hierfür wurden zwei Strömungsarten
hinsichtlich ihrer ef zienzsteigernden Wirkung für zwei Lebensmittelbestandteile Xanthan und Stärke untersucht. Im Ergebnis konnte der…
View 14 Reads
Andrew Walsh
A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities
Article Aug 2017
Andrew Walsh · David G Dolan · Andreas Flueckiger · Kelly Waldron
This article will present a new scale based on the process capability of a cleaning process that can be used to evaluate the probability of
cross-contamination by compounds manufactured in a shared facility or equipment train. This approach can be used to evaluate sample
results from cleaning validations or monitoring studies for all types of cleaning, including manual, semi-automated, or automated cleaning
View 473 Reads

Jessica Hedge
Mycobacterium chimaera Isolates from Heater–Cooler Units, United Kingdom
Article Jul 2017 · Emerging infectious diseases
Jessica Hedge · Theresa Lamagni · Ginny Moore · Meera Chand
View 16 Reads
Mo Ovais
Setting Cleaning Validation Acceptance Limits for Topical Formulations
Article Jan 2008 · Pharmaceutical Technology
Mo Ovais · Lai Yeo Lian
Pharmaceutical manufacturing requires validation of cleaning methods to ensure that the contaminants from one product to another are
reduced to safe and acceptable levels. The current available methods for generating cleaning validation acceptance limits can be used
effectively for both active pharmaceutical ingredients and nished products. A need still exists, however, for using these approaches rational…
View 1,141 Reads

Jessica Hedge
Mycobacterium chimaera Isolates from Heater–Cooler Units, United Kingdom
Article Jul 2017 · Emerging infectious diseases
Jessica Hedge · Theresa Lamagni · Ginny Moore · Meera Chand
View 23 Reads
Andrew Walsh
Cleaning Limits-Why the 10-ppm Criterion Should Be Abandoned
Article Jan 2016 · Pharmaceutical Technology
Andrew Walsh
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into to next
product has been employed for many years. It is, however, arbitrary and does not take into account advances in toxicological risk-assessment
methodologies that allow for robust and scienti cally supportable approaches to establish safe or acceptable levels of a drug from one…
View 333 Reads

Lisa Wiesner
Topical otic drugs in a multi-purpose manufacturing facility: A Guide on Determination and Application of Permitted Daily Exposure (PDE)
Article May 2017 · Pharmaceutical Development and Technology
Lisa Wiesner · Maarten Prause · Ester Lovsin Barle
Due to newly introduced EU GMP guideline for Medicinal Products for Human and Veterinary use (PIC/S, 2015), product speci c PDE for
toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. EMA (2014) guidance on
setting PDE limits so far focused on systemic administration routes such as IV, oral or inhalation. This manuscript wants to give guidance o…
View 41 Reads
Tim Sandle
Establishing a Contamination Control Strategy for Aseptic Processing
Article Mar 2017 · American Pharmaceutical Review
Tim Sandle
This article has introduced some of the important elements that make up a contamination control strategy for aseptically lled products.
There are of course other elements such as cleaning validation and the environmental monitoring strategy? the purpose here was to focus on
There are, of course, other elements such as cleaning validation and the environmental monitoring strategy? the purpose here was to focus on
the core parts of the contamination control strategy and to highlight areas that are sometimes overlooked. Some of the topics selected are…
View 1,143 Reads

Matteo Federici
added a Poster related to Cleaning Validation
Wirksamkeit von vier Reinigungsmitteln zur Dekontamination von Zytostatika auf verschiedenen Ober ächen des Herstellungsroboters
APOTECAchemo
Poster May 2017
Matteo Federici · Irene Krämer · Jacopo Raffaelli · Rudolf Schierl
View 91 Reads
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