- Cleaning validation
is a process to ensure that equipment cleaning procedures are removing
residues to predetermined levels of acceptability. Although
"equipment cleaning" is part of current Good Manufacturing
Practice requirements the term
"cleaning validation" was not popular
until late 1980s. The need for a systematic approach to proving the
effectiveness of all the cleaning procedures was achieved in
1993 with a revised Food and Drug Administration Inspection
Guide on Cleaning Validation.
- The objective of the
cleaning
validation is to verify the effectiveness of the cleaning
procedure for removal of product residues, degradation
products,
preservatives, excipients and/or cleaning agents so that the analytical
monitoring may be reduced to a minimum in the routine phase.
In addition one needs to ensure there is no risk associated with
cross contamination of active
ingredients.
- High risk products,
such as
penicillin's, are a major concern in the cleaning validation
field. Sensitive sampling methods require development and must be
applicable to each specific piece of equipment used. Due to the
possibility of inter-product contamination, highly sensitive
analytical methods such as LiquidChromatography are required for trace
level analysis.
- Pharmaceutical
plants must have visually clean equipment to operate according to good
manufacturing practices. Formulators must visually inspect manufacturing
equipment for cleanliness before formulation work
begins (1).
Manufacturers establish and perform visible cleanliness and analytical
methods to ensure regulatory compliance. An analyst conducts a visual
inspection and confirms visible cleanliness before taking swab samples
for chemical analysis (2). The formulator of the subsequent batch
conducts a visual inspection before manufacturing work begins. A
correlation between available analytical data and visible
cleanliness of manufacturing
equipment over an extended period
of time can expand the practice of performing visual inspections in lieu
of swab sampling
- Common analytical
techniques in the validation process include HPLC, spectrophotometry
(UV/Vis) and TOC. HPLC and UV/Vis are classified as specific methods
that identify and measure appropriate active and substances. TOC is
classified as a non-specific method and is ideal for detecting all
carbon-containing compounds,
including active species, excipients,
and cleaning agent. |
General
Information
- Introduction to
Cleaning Validation
- Cleaning Validation,
how clean is clean?
- Process Validation
Support
- Cleaning Validation
- An Overview Of
Pharmaceutical
- Cleaning Validation
- Cleaning
Procedures
- Pat For
Pharmaceutical
- Pharmaceutical
Applications
- Simplifying
pharmaceutical cleaning validation
- Pharmaceutical
Applications for TOC
Equipments
Needed
- Medical Ultrasonic
Cleaners
- Welcome to Tooltek
Engineering
- Ultrasonic
Cleaners
- Aqueous cleaning and
disinfection
- Sanitary Spray Balls
for Critical Cleaning
- Our Standard
Products
- Automatic Ultrasonic
Cleaning Machine
- Pharmaceutical
Equipment Ultrasonic Cleaners
Examples &
Calculation
- Pharmaceutical
Cleaning Validation
- Total Organic Carbon
Analysis
- A Roadmap
to an Effective Cleaning Program
- GMP/Validation
- Validation
Services
Technology
- Advanced
Technology
- Analytical Method
Development
- Direct Swabbing and
Surface Recovery
- IMS for
Cleaning Verification
- In situ
spectroscopic cleaning validation
- Ion trap mobility
spectrometry
- Smiths
Detection
- A High
Throughput
- Process
Technology
-
Cleaning Validation Technologies
Guidelines
- Cleaning Validation
Guidelines
- Guide To Inspections
Validation
- Health
Products
- Guidance on
aspects
- Proposed Validation
Standard
Patent
- Method For the
Assessment
- Method Of
Removing
- Cleaning
Compositions
- Use Of
Surfactants
|
Process
-
- Pharmaceutical
Industry Solutions
- Method Development
of Swab Sampling
- Measurement &
Validation
- Validation: An
Essentiality In The Pharmacy
- Validation Of
Cleaning Methods
- Requirements For
Process
- Cleaning Validation
in Active pharmaceutical
- Effective Cleaning
and Sanitizing
- Evaluation Of
Cleaning
-
- Global Programme For
Vaccines
- Continuous
Monitoring
- Analytical Services
Laboratory
- Development of an In
Situ Spectroscopic Method
Detergents &
Surfactants
- Low-Foaming Powdered
Detergent
- Selecting the Right
detergent
- Aqueous
Cleaning
- Ionscan tops Hplc
- Liqui-Nox
- Surfactant-Enhanced
Aquifer Remediation
- Shimadzu
- Superior
Performance
Analysis
- Total Organic Carbon
Analysis
- Cleanliness &
Contamination
- IonScan-LS
IMS
- Mid Atlantic
Region
Material
- A Brief Introduction
to API / HAPI Plant Design
- Layton
Technologies offers the greatest versatility
- Teledyne
- Testing a New
Chromatography Column
for Cleaning Effectiveness
Company
Profile
- Our philosophy,
guidelines and goals
- Contamination
Control
- Quality Analytical
Services
-
Gibraltar
Company Profile
Consultants
- Jm
hyde
- Who We Are - Those
We Serve -
Our Facility
- Cleaning Validation
Technologies
- Cmac
consultancy
- Cleaning Validation
Acceptance
- pharm
- Taratec
- Soli Pharma
Solutions
Order The CD ROM
Today |