Effects of Volatile Components on Rinse Sampling Recovery by TOC Analyses (original) (raw)
Related papers
Biotechnology and Bioengineering, 1995
Validation of direct surface swabbing procedure in conjunction with total organic carbon (TOC) analysis is described for a biopharmaceutical product manufacturing operation. The swabbing technique was found t o be very effective in reliably detecting very low levels of residuals for diverse process streams (limit of detection of approximately 0.5 pgicrn'). However, contaminant recovery was significantly dependent on both the type of contaminant and the processing surface. This study serves as a guide for designing effective cleaning validation protocols based on direct surface swabbing techniques. 0 1995 John Wiley & Sons, Inc.
Cleaning Validation: An Important Aspect in Accessing Pharmaceutical Residues
2014
The quality should be built in to the pharmaceutical product and the margin of errors should be none because it deals with the health. Pharmaceutical product can be contaminated either by previous drug manufacturing process in the industry, other exicipents, API, air borne contamination, dust, raw materials, etc. The cross contamination of the product can occur by the same or by other previous products. So proper cleaning should be ensured in order to avoid contamination. The interaction of pharmaceutical product with other substances may cause severe degree of damage to the quality, efficacy and safety of the product. Due to these reasons the cleaning of the equipment and various accessories should be done in order to prevent the contamination of the processing product and so the quality of the product can be retained. But cleaning alone cannot make things sure that there is no more interaction, so after cleaning the effectiveness of the cleaning can be measured by the validation. ...
Analytical Methods for Cleaning Validation
Residue identification 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 identification. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. ______________________________________________________________________________
Pharmaceutical Cleaning Validation
A cleaning process should remove materials such active and non-active pharmaceutical ingredient, and microorganism. Manufacturing and cleaning equipment must be designed for effective and consistent cleaning to avoid cross-contamination and the cleaning processes must be verified as effective. This project paper provides the importance of cleaning validation and the regulatory requirements, cleaning methods, validation strategy, product and equipment grouping strategy, sampling technique, acceptance criteria, sampling tools, clean hold time, dirty hold time. Cleaning validation refers to establishing documented evidence providing a high degree of assurance that a specific cleaning process will produce consistent and reproducible cleaning results that meet a predetermined level. The program begins cleaning method introduction, followed by worst case product, acceptance criteria, cleaning validation sampling, sample analytical method and sampling tools. In Pharmaceutical Industry, cleaning validation must be performed using a pre-approved protocol. Selection of appropriate sampling to demonstrate that residues are removed to an acceptable level is vital for the success of cleaning validation. In addition, use of sampling techniques such as swab and rinse and thorough visual inspection can reduce the number of samples required for cleaning validation. Ongoing monitoring is required to prove the effectiveness of the validation program. This project covers the grouping strategy, validation sampling, acceptance criteria, clean and dirty hold time.
Regulatory Aspects of Cleaning and Cleaning Validation in Active Pharmaceutical Ingredients
Asian Journal of Pharmaceutical Research and Development, 2018
Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. In the manufacturing of the pharmaceutical products, it is a must to reproduce consistently the desired quality of product. Residual material from the previous batch of the same product or from different product may be carried to the next batch of the product, which in turn may alter the quality of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning method employed within a facility consistently controls potential carryover of product including intermediates and impurities, cleaning agents and extraneous material into subsequent product to a level which is below predetermined level The purpose of this review is to provide information about importance of cleaning validation of API in pharmaceutical industry and this information is in accordance with the regulatory guidelines.
A Review on Cleaning Validation for Pharmaceutical Industry
INDIAN RESEARCH JOURNAL OF PHARMACY AND SCIENCE, 2017
The objective of this review is establishment of importance of cleaning validation in pharmaceutical industry. It provides background on cleaning validation in order to prevent the potential problems which may have effect on safety, efficacy and quality of pharmaceutical product being manufactured. Regulatory agencies like US FDA have recommended having an effective cleaning validation program. It briefly provides an overview on cleaning mechanisms, cleaning agents, methods of cleaning, sampling techniques, methods to determine acceptance criteria and analytical techniques to identify and quantify drug residues.
Overview of Cleaning Validation in Pharmaceutical Industry
Journal of Harmonized Research in Pharmacy, 2018
Introduction: Cleaning validation is necessary to establish consistency and uniformity in equipment cleaning procedures by implementing practices that have been found acceptable. It must be accepted that in case of cleaning validation process, as with validation of other processes, there are several ways of validating the process. Ultimately, the assessment of any validation process depends on availability of scientific data that demonstrates that the process is able to consistently perform as expected and produces an outcome that meets predetermined specifications. In addition, the levels must be acceptable to the regulatory authorities responsible for ensuring the safety and quality of the pharmaceutical products.[1] Objective: The objective of cleaning validation is to demonstrate with adequate documented evidence that the equipment / utensil cleaning procedures can consistently remove residues of Abstract: An essential part of any pharmaceutical manufacturing facility which operates under cGMP Guidelines and adheres to Quality Systems Regulations (QSR), is the availability of well-developed and validated cleaning procedures for all installed equipment. This will ensure that the cleaned equipment is free from residues of active ingredient from the previous product manufactured on that equipment and also from traces of detergent, if used in cleaning process. Additionally, the equipment will also be free from microbial contamination which can be carried forward into the next batch.Documented evidence that demonstrates effectiveness of the cleaning methods employed within the facility to consistently reduce potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to levels which are below predetermined limits is the key to produce quality products.
Cleaning validation in analytical development: Current challenges and future prospectives
International Journal of Pharmaceutical Chemistry and Analysis
Cleaning validation is a prominent and ideal practice which is employed in industrial aspects to provide utmost shielding to develop drug products, so that a cleaning practice removes the particulate matters, chemicals, as well as the contaminant pathogens reside in active ingredients of drug product in a piece of apparatus, which are produced or being manufactured. The cleaning validation is established as the pre-eminent process that ensures the efficiency, safety, consistency of pharmaceutical equipment and manufactured product of assured quality. The utmost cleaning practice during manufacturing of drug substances affords the appropriate operator safety measures, organized calibration, description and routine monitoring of equipments, Sampling procedures, acceptance criteria's and detection limits of analytical methods. This also lead to systematic data analysis for estimating of probable contagions in product batches builds up. Abortive cleaning may lead to adulterated product that may be originated from preceding batches, clean-up agents or other superfluous materials produced during methodology. Hence to avoid the harmful contamination, sources, safety measures clean-in-practice is highly recommended as per regulatory and stability point of view. The present review intensifies the current challenges, basic mechanisms and future implication of cleaning validation in various analytical development firms and research organizations.
Non-specific methods for detecting residues of cleaning agents during cleaning validation
Chemical Industry and Chemical Engineering Quarterly, 2011
Cleaning validation procedures are carried out in order to assure that residues of cleaning agents are within acceptable limits after the cleaning process. Cleaning agents often consist of a mixture of various surfactants which are in a highly diluted state after the water rinsing procedure has been completed. This makes it difficult to find appropriate analytical methods that are sensitive enough to detect the cleaning agents. In addition, it is advantageous for the analytical methods to be simple to perform and to give results quickly. In this study, three different non-specific analytical methods are compared: visual detection of foam, pH and conductivity measurements. The analyses were performed on different dilutions of the cleaning agents Bactericidal Hydroclean and Tickopur R33. The results demonstrated that the most appropriate method for these detergents is conductivity measurements, by which it is possible to detect concentrations of cleaning agents down to 10 ?g/ml. In th...