CLEANLINESS AND CONTAMINATION CONTROL

VALIDATION OF MEDICAL DEVICES AND

CLEANING SYSTEMS

CSMA
INTRODUCTION
Regulatory approval, prior to product launch, is becoming increasingly
important in the healthcare industry worldwide. In the medical device sector,
the surfaces of implant devices are of critical importance as they control
many clinical properties including the immediate response from the
biological host. Surfaces are becoming more complex both in terms of
chemistry and geometric form. For example, new-generation cardiovascular
stents need to accept drug-loaded polymer coatings and orthopaedic
implants, for knee and hip replacement, have complex shapes with beaded
or porous surfaces which are coated with hydroxy-apatite to aid tissue
adhesion. This makes cleanliness critical in order to optimise coating
performance e.g. wettability and to minimise toxicological effects in the
body.
Over the last 15 years CSMA Ltd. has built up its own unique level of
expertise in the application of surface analysis to medical device technology.
If your company requires …….
● Characterisation of product surface cleanliness
● Validation of new or existing cleaning equipment
● Provision of a validated turnkey installation or continued process monitoring,...CSMA is uniquely equipped to
provide your needs.

TYPICAL CLEANLINESS VALIDATION PROJECT.

The medical device manufacturing process may include milling, turning, polishing, lapping, de-burring with
intermediate cleaning stages or more delicate operations such as laser treatment, printing or surface modification.
The former processes will almost certainly introduce contamination onto the surface.
Surface analysis techniques such as XPS or SIMS are valuable tools in understanding
which of these manufacturing agents remain after cleaning and how easily they are
removed. With the correct and appropriate sample preparation, e.g. controlled laser
cutting, even the most difficult geometries can be accessed.
A TYPICAL CLEANING VALIDATION PROJECT WOULD INCLUDE THE FOLLOWING :-
● Chemical characterisation of contaminants
● Effects of each manufacturing process stage on surface condition
● Production of finalised cleaning specification
● Characterisation of detergents to be used
● Assess Cleaning Stages and Final validation
● Continued System Monitoring
WHY SURFACE ANALYSIS?
Regulatory bodies, such as the FDA, increasingly require companies to submit general procedures on how
cleaning processes will be validated and contamination controlled. The following objectives should be met:-
● Identification of residues to be removed, detection and sampling method
● Effectiveness of the steps used to clean the product
● Identification of detergent residues deposited in cleaning stages
● Effectiveness of final cleaning stages to remove detergent residues if any
Residues and contaminants may be particulate or thin film and not necessarily visible to the naked eye or
microscopy techniques. The regulatory bodies will normally accept any method of detection.
The analytical method needs to be chosen to give the right specificity and sensitivity to detect residuals or
contaminants at very low levels. If levels are not detected by a particular technique it does not mean that
there is no residual contaminant present after cleaning - a negative test may also be the result of a poor
sampling technique.

DIRECT SURFACE SAMPLING BY SURFACE ANALYSIS -

XPS AND SIMS
Direct surface sampling allows dried out and insoluble residues to be
analysed. Measuring the actual component surface using surface
analytical techniques ensures that the true and complete residue/surface
is characterised. This is unlike rinse or swabbing techniques which only
analyse what can be removed by the media used and not those species left
behind.
Techniques such as XPS and ToFSIMS give highly sensitive surface
characterisation from the uppermost 1-5nm of the surface. Furthermore,
the condition of the surface can be assessed at the same time, for
example, if cleaning is part of a passivation process, both residue content
and degree of passivation can be characterised by looking at the species associated with the residue and
metal : metal oxide ratios. SIMS depth profiling is also used routinely to monitor contaminant depth
distributions and oxide thickness.

BENEFITS TO CUSTOMER
XPS, ToFSIMS and SIMS depth profiling techniques are routinely used to provide information on the
cleanliness of medical devices which is subsequently used as the basis for regulatory submission and
approval. Some of the benefits from surface analyses include :-
● A cost effective direct surface sampling methodology
● Contamination analysis and quantification
● Affects on surface properties of cleaning media
● Auditing medical device production and cleaning systems

CSMA provides a complete surface analysis service to industry to accommodate every level of
demand:
● rapid turnaround analysis (24 hours) ● reverse engineering and competitor analysis

● problem solving and failure analysis ● materials and product development

● litigation and expert witnesses ● patent registration / infringement

● training courses

For further information contact Tony Kinsella, Managing Director,

CSMA Ltd, Queens Road, Penkhull, Stoke-on-Trent. ST4 7LQ.

Tel: +44 (0)1782 764440 Fax: +44 (0)1782 412331

Email: tonykinsella@csma.ltd.uk Website: www.csma.ltd.uk

CSMA Ltd is a subsidiary of your partner in materials & technology