Awarded the Journal of GXP Compliance

2012 Article of the Year

MICRO BIO LO GY TO PIC S

Contamination Control in
the Compliance Program
Scott Sutton

IMAGE SOURCE,
IM
O
MEDIC
MEDICALRF.COM/GETTY IMAGES

Microbiology Topics discusses various topics in microbiology of practical use in validation and compliance. We intend this column to be a useful
resource for daily work applications.
Reader comments, questions, and suggestions are needed to help us fulfill
our objective for this column. Please send your comments and suggestions
to column coordinator Scott Sutton at scott.sutton@microbiol.org or journal
managing editor Susan Haigney at shaigney@advanstar.com.

IMPORTANT
PORTA POINTS
Thee follow
following impor
important point
points are discus
discussed:
t
The
to goo
good manufacturing

The contamination
co mina
control plan
n is central
cen
an cturing
practice,
describing
to create
actic , des
ib g the
th procedures
procedu es and
and policies
poli s designed
s
products
under
controlled
p
odu s un
der co
ntro led conditions
ond on
t
The contamination control plan
covers all p
phases of a facilitys
p
y
status
tatus
a s
tt
The contamination
nt
control plan
lan iss a comprehensive document,
describing control of incoming contamination and measures
designed to minimize their impact
t
Consistency and application are key to successful execution of the
contamination control plan.
INTRODUCTION
Development of a contamination control plan is critical to the success of
aseptic, terminal sterilization, and non-sterile manufacturing facilities. This
is most obvious in the aseptic arena, where the US Food and Drug Administration has issued clear regulatory guidance on the need for control of
contamination at all stages of the process. What is less obvious is the even
greater need for a plan to address contamination control in non-sterile manufacturing. This need only becomes obvious after a problem has arisen
frequently a problem in contamination control that requires product recall.
The contamination challenge in non-sterile production is different from that
in aseptic production. The objective in aseptic production is to exclude all
microorganisms from the finished product; in the non-sterile environment
it is to control the types and numbers of microorganisms in the finished

58

Journal of GXP Compliance

Scott Sutton

Figure 1:
Example Fishbone diagram for contaminated product.

Cause & Effect Diagram for Potential Causes of Contaminated Product

Personnel

Training

Raw Materials

SOP not
Correct

Inadequate Hand
Sanitization

Raw Material/Components
Received Contaminated

No Evidence
of Training

SOP Program
Poor Personal Hygiene
(piercings, jewelry,
makeup, illness)

Raw Materials/Components
Contaminated on Sampling
Raw Materials/Components
Contaminated on Storage

Operators Ineffectively
Trained

SOP not Relevant SOP

Followed not A3&))"

Inadequate PPE
(foot, coat, face, hair)

Training Program
not in place

Proficiency
Not Reviewed
Regularly

Proficiency not
Demonstrated

Contaminated Product
Sample Hold Compromised
Inappropriate Materials of
Construction (difficult to sanitize,
particulate generation, etc.)
Lack of Air
Quality Control
Air Quality
Compromised

H
HVAC-HEPA
Compromised
Water Generation
System Compromised

Inadequate
Pest Control
Ineffective
Sanitization Agents
+ ,*-1&&)&15
,#

Cleaning-Sanitation
Compressed
Agents
Gases
Compromised Product Contact
Surfaces
ot-to-Lot Cleaning
C
g Ineffective
Ine
ve
Lot-to-Lot
//53"r
9
//53"r
"0&!2)0
9
"0&!2)0

&,2/!"n
9

&,2/!"n
n-Prod
tact
Non-Product
Contact
SSurfaces

Delivery (Hoses)
(H
Water Delivery
Comp
promised
Compromised
W
Q
Water
Quality
Comp
Compromised
P
Piping
Issues
(d
(dead-legs,
reverse
inclines, etc.) Source
e Water
W
Compromised

O er Water
Wa r Issues
Other
9 +!&+$ Wa
9
1+!&+$
Water
9
/&--&+$
&-"0

Sampling Error

Inadequate Removal
,#
&0&)"
"/&0

Organic Load

Transfer/Sampling
Issues
Sample Transport Compromised

Shift of Environmental

&,2/!"+
#/,*

Sensitive to
Resistant Species

Contamin
Contamination of
Cleaning Implements

Hold times not validated

(process as well as
equipment clean
ty h
and dirty
holds)

qu
ration
Inadequate
Separation
off C
Clean and
rty Operations
atio
Dirty
de
Inadequate
Protection
om Uncontrolled
From
Env
Environment

Cleaning
and
Sanitization
Clean
ng a
d Sa
itiza n
Process

Facility
Fac
acili y

products. Regulatory action has extended this consideration even into the realm of personal care products
(e.g., cosmetics, toiletries, and soaps).
Contamination control is central to compliance. The
whole point of current good manufacturing practice
(CGMP) is to produce safe and effective medications
(1). As an indication, the word contamination or its
variants appears no fewer than 24 times in 21 CFR
211. One of the most frequent cause of drug recalls,
lack of sterility assurance, relates directly to the inability of the manufacturer to document adequate protection against contamination by adventitious bioburden.
See the Reference section for a historical review (2) and
a biotech case study on this topic (3).
Diverse markets such as pharmaceuticals, medical
devices, diagnostics, and personal care products have
operated historically under different CGMP. However,

the considerations for contamination control are similar and can be approached from the perspective of root
cause analysis (4). Use of a Cause and Effect diagram
can be an excellent tool in the determination of likely
routes of contamination after the fact during an investigation. It can also be used as a proactive learning tool
for the development of the contamination control plan
(see Figure 1). For those more comfortable with Six
Sigma procedures, this can be revisited as an Ishikawa
Diagram (see Figure 2). The main point here is to
identify, and come to agreement, on the likely causes of
potential problems.
A more traditional proactive approach to risk
management might be through use of failure mode
and effects analysis (FMEA), which can be extremely
useful in determining the most important aspects of
control for your process (5).
Autumn 2011 Volume 15 Number 4

59

MICROBIOLO GY TO PIC S

Figure 2:
Example Ishikawa diagram for contaminated product.

Cause & Ef$#!2
'%0+
$-0
-2#,2'*
31#1
-$
-,2+',2#"
0-"3!2
: 

Manpower
Materials
Inadequate Hand
Sanitization

Raw Material/Components
Received Contaminated
Raw Materials/Components
Contaminated on Sampling

Methods

0-8!'#,!6

Not Reviewed
No Evidence Regularly
of Training

Raw Materials/Components
Contaminated on Storage

,"#/32#


(foot, coat, face, hair)


0-%0m

Operators
Ineffectively
Trained

--0
#01-,*
6%'#,#

(piercings, jewelry,
makeup, illness)
0-8!'#,!6
,-2
#+-,1202#"


,-2

,-2

Followed
Correct

#*#4,2


not A4'* *# '*32'-,1
 

Tr',',%
0-%0+

not in place

0-!#"30#
Inappropriate to Specs
Unvalidated

-,2+',2#"
0-"3!299
Sample Hold Compromised
Inappropriate Materials of
Construction (difficult to sanitize,
particulate generation, etc.)

Inadequate
#12
-,20-l

Lack of Air
Quality Control

Ineffective
Sanitization Agents
,!-+.2' '*'26
-$
Cleaning-Sanitation
Compressed
Agents
Gases
Compromised
0-"3!2
-,2!2

Surfaces

Air Quality
Compromised

HV
A Compromised
Water Generation
System Compromised

Water Quality
Compromised
Compro
'.',%
113#1

'.
(dead-legs,
reverse
(de
e
inclines, etc.) Source Water
Compromised
ompro se

Other Water Issues

;
2,"',%
ater
2,"
 er
;
0'..',%
'.#1
0'..' '.#1

Transfer/Sampling
Issues
Sample Transport Compromised

Shift of Environmental
'- 30"#,
$0-+

Sensitive to
Resistant Species

Lot-to-Lot Cleaning Ineffective

;
0064#r
;
#1'"3*1
;
#1'"3
;
'- 30"#n
30"#
-,0-"3!2
-,2!2
-,0-"3
!2
Surfaces
Sur

W2#0
#*'4#06
-1#1

#*'4
Compromised
mpro

Sampling Error

Inadequate Removal
-$
'1' *#
# 0'1

Organic Load

Hold times not validated

(process as well as
equipment clean
and dirty holds)

Inadequate
Separation
equate Sepa
of Clean
Clea and
: '026<
.#02'-,1
<


Contamination
of
Contaminat
Cleaning Implements
Imp

Management

,"#/32#
0-2#!2'-,


#
0
,
From Uncontrolled
Environment

Machinery
Mach
ery

Mother
h Nature
N t

COMPONENTS
OMPONENTS OF A STRONG
G
CONTAMINATION CONTROL PLAN
The contamination control plan and the protocol
governing the program are essential documents
useful in providing the rationale and methods used
to accomplish three tasks:
t
Minimizing the bioburden throughout the
manufacturing processes
t
Minimizing the level of batch residual crossover contamination
t
Minimizing the level of cleaning material residual contamination.
This article examines the components of the
plan in terms of specific areas of interest in meeting
these three key objectives.
Phases of Manufacturing Operation
The contamination control plan must take into account different stages of facility operational status.
60

Journal of GXP Compliance

At a minimum,
these include the following:
in
t
Commissioning and initial start up
t
Ongoing operations
t
Shut-down for regular maintenance
t
Start-up after scheduled shut down.
These phases will not have the same level of
contamination control. A good plan will discuss the
concerns specific to each of these phases.
Validated Methods
All measures of bioburden in a facility will be
indirect. Bacterial cells cannot be counted on a
surface or in the air. The microorganisms must be
transferred to an agar plate (or some other mechanism) and colony-forming units (CFU) counted. If
the assumption is made that the transfer of microorganisms from the air or from a surface to agar
is consistent, then these numbers can be used to

Scott Sutton

estimate trends over time. This assumes that the

nutrient agar is capable of growing the microorganisms to visible colonies. As residual disinfectant on
a surface may impede the growth of microorganisms, neutralizers are frequently incorporated into
the growth media (e.g., Dey-Engley Agar, MCTA).
The contamination control plan should describe the
sampling methods used, and how these methods
are to be validated for the conditions of use (6).
The facility should be disinfected regularly using
validated sanitizers and sporicides. The contamination control plan should describe the methods for
testing and rationale for acceptance of materials to
be used in the ongoing program of disinfection. The
plan should ideally describe the in vitro or laboratory tests to evaluate the sanitizers, including the
identification of the most resistant microorganisms
found in the
h facility as well as the most difficult-todisinfect materials
in the facility. This is also where
m
the method
sanitizhod for on-going
-goi evaluation
aluation of the san
erss base
based
monitoring
ed on environmental
ronm
monito g data will
be rec
recorded.
disinfection regimens
corde Thee choice of disinfec
egim s
should
u be reevaluated
uld
uated annually,
an al and the ccontaminant mina
tion
should
how
thiss eva
evaluan control plan
n sh
uld describe
escr be h
w th
ua
tion will occur.
Itt iiss alsoo critical
cr ticaal too have
av appropriate
appro
ropriaattee microbiomicrobio
microb
biological
specifications
ogical methods for the relevant
v
cif
plate counts less than 20 CFU are notoriously
unreliable. Traditionally the countable range for
a standard sized petri dish is 25-250 (or 30-300)
CFU/plate. These lower limits (limits of quantification) are routinely ignored when setting product
and environmental specifications, thereby sacrificing accuracy and precision. Similarly, the upper
limits (250 or 300 CFU/plate) are set for particular
microorganisms on standard-sized plates, smaller
plates, or organisms that produce larger colonies
will have lower numbers as their upper limit. These
will require dilutions as appropriate to measure the
same specification.
Know the Enemy
A successful contamination control plan is intended
to provide the most useful information on the microorganisms present while at the same time show-

ing fiscal responsibility. The FDA aseptic processing

guidance document recommends genetic identification of all organisms isolated from the manufacturing environment on a regular basis. This is a
laudable goal, but few of us have anything near the
required budget to accomplish this task. In all honesty, it is reasonable to wonder if the effort is really
necessary. The numbers of CFU from validated sites
(i.e., viable air and surface, non-viable) is sufficient
to provide a measure of the state of control of the
facility. However, periodic cataloging of the resident
microflora (at least to the species level) will provide
a good check on the continued effectiveness of the
disinfectants in use (7). Shifts of bioburden to spore
forming microorganisms will be strong evidence of
the need for use of a sporicidal agent. Occasionally,
this effort will also pick up shifts among non-sporeforming organismsthis is not due to resistance
but rather ecological shifts towards species more
naturally
disinfectant
rally resistant
re ant to thee disinf
nt iin use.
The
he considerations
cons
ations in thee non-sterile
sterile facility
ity
are
a similar, as we need
nee proof
of thatt the sanitization
san ation
program
used
progr m u
e is eeffective
ct e and the regular use of
sporicidal
poric a agents
g nts appropriate.
appro riat The contamination
control plan
must address how the sanitization
p
program
willl b
bee m
monitored
efficacy.
program w
prog
on
nito
ored
d for ef
fficaacyy.
Control Incoming Bioburden
The first step in any control program is to control
contamination at the very beginning of the process.
This includes raw materials (e.g., excipients, API,
water) and the primary containers. All materials
should be tested for incoming bioburden against
documented acceptance criteria. Part of the incoming bioburden will also include water used as an
excipient to the process. The GMPs for pharmaceuticals, biologics, medical devices, and diagnostics
all provide instruction on this point.
Appropriate Gowning
The gowning methods and materials are of critical
importance to minimization of contamination. The
primary source of contamination in most controlled
areas will be the personnel. The contamination
control plan must address whether it is designed for
Autumn 2011 Volume 15 Number 4

61

MICROBIOLO GY TO PIC S

aseptic gowning procedures or protection of personnel

in non-sterile manufacturing facilities. All personnel
should be well trained in appropriate gowning practice
and behavior. The contamination control plan should
describe the rationale for the level of gowning chosen,
the frequency of gown cleaning, personnel behavior,
and the acceptable gown materials for the type of
manufacturing process.
Training
Operator training is critical to contamination control. No supervisor can be present at all locations at
all times. Each operator must be aware of his or her
role in contamination control and how to minimize
the risk to batch integrity. Minimal skill sets in
relation to product protection and sampling should
be described by job function in the contamination
control plan.
an This is most effectively accomplished
using a wel
well-designed and enforced standard operatingg p
procedure
(SOP)
oce
OP) system
m (8).
Controlled
ntroolled Environments
ronment
Control
the envi
environment
nttro and monitoring
nito ing of th
onm t iis ann
other
he critical element
men of the
the contamination
contam nation control
control
plan. Large
portions of this can be addressed byy the
g p
corporate
orporate
rp
poratte environmental
enviroonmental
al monitoring
monito
tor ngg (EM)
(EM
M master
mast
masster
plan
lan (which provides rationale
na and consistency
o
for
a single EM philosophy across the different facilities
of the corporation) or the site environmental master
plan (which provides consistency and detailed
instruction for the various manufacturing buildings at a given site). The contamination control plan
should cite the relevant documents and their role in
contamination control.
The appropriate EM plan for non-sterile manufactures and for active pharmaceutical ingredient (API)
manufacturers is not well defined from a regulatory
perspective. There are no strong recommendations
such as those seen for the environmental monitoring of aseptic facilities; however, the absence of
regulatory guidance is not the same thing as the
absence of need for the activity. EM is useful for
determining the state of control of the facility and
so is an important part of the monitoring program
for all manufacturers (6).
62

Journal of GXP Compliance

Validated Sanitization and

Sporicidal Procedures
The efficacy of the sanitizers and sporicides used
in the program must be demonstrated in a study
designed to test their efficacy on the materials of
construction and against resident microorganisms
found in the facilities governed by the contamination control plan. This can be done optimally in the
following four-step process:
1. Suspension test of efficacy. This is a screening effort using your candidate agents against
lab strains of indicator organisms as well as a
variety of the microorganism species found in
your facility. The goal of this assay is to determine the most resistant microorganism(s) for
the next step.
2. Coupon study. Using the representative organisms (e.g., gram positive, gram negative, spore
former, yeast, and mold) and organism(s) identified in
i thee previous
prev us study,
stud test
st the
t efficacy
cacy of
o
the san
sanitizing
on coupons
ing agents
ag
pons of
o materials
terials
found in the
facility. The
he faci
Th purpose
urpose oof this
is test iis
to
demonstrate
t dem
mo stra eefficacy
ca on these materials using
procedures.
i g thee appropriate
ppropriat application
app
3. Mock sanitization study.
y This studyy
provides
evidence
prroviidess re
rreal-world
eal-w
world ev
vviidence of efficacy.
effficcacy
a y. Let
Leet
a re
representative room go untouched for a
period of time to become contaminated.
Take bioburden samples throughout the room,
and then sanitize the surfaces and repeat the
bioburden sampling. The samples taken after
cleaning should be far less contaminated than
the first set.
4. Confirm efficacy from environmental monitoring. The final step in validating the sanitization program will be ongoing evidence that
the program allows the facility to operate in a
state of control.
The sanitization program will ideally consist of
a qualified disinfectant and sanitizing agent, used
appropriately (concentration and contact dwell time
observed) as the primary agent. This will then be
periodically rotated with the use of a sporicidal
agent (also validated for effectiveness) (9, 10).

Scott Sutton

Well-Defined and Understood

Manufacturing Processes
The manufacturing process should be evaluated
for its potential to limit or eliminate bioburden.
The two common methods for performing this are
either a HACCP-type or a FMEA approach. The
use of organic solvents, heat, or other inhospitable
activities can greatly reduce bioburden of a process.
For example, the contribution of compression (and
associated shear) should be evaluated for a potential
reduction in risk of excessive microbial contamination. The contribution of the finished product water
activity should also contribute to this analysis. Process bioburden reduction steps should be factored
into the contamination control plan on a processby-process basis.
Of particular importance in this evaluation for
the potential
ia for microbial contamination of the
process are
re cleaning steps, equipment hold times,
HVAC,, con
control level
el oof environments
ronmen for critical
critic
tasks,
open-system
sks, open-s
o
m versus
vers closed-system
losed-sy m operaope
tions,
bioburden
monitoring,
specificc
ns, biob
n monito
g, and oothers spe
to the
process. Ass an exa
example
the imp
importance
h p
he
pl off th
ta e of
thee bioburden control
point
issue,
strong
ontr l po
nt is
ue, tthere
here iis a st
ong
regulatory
in Europe
products
g
y expectation
p
p that p
sterilized
terilized
err ilized
i d by filtration
f ltraation
n should
sho
hoould have
haave a pre-filtration
pre-filtratio
pree-f ltrration
n
bioburden
ioburden of not more than
n 10 CFU/100
/1 mL immediately before the sterilizing filter (or be subjected
to dual filtration in series).
Finally the contamination control plan should
cite the need for clear SOPs on all aspects of manufacturing, monitoring, and control. These SOPs
are critical for training, documentation, and batch
release.
Minimization of Batch Residual
Crossover Contamination
The contamination control plan should also address
the potential for a batch to be contaminated by
material from the previous batch manufactured using the same equipment. The contamination control
plan should describe the methods by which this
likelihood is minimized.
The concern over batch residual crossover is
most relevant when there is more than one product

manufactured at a site. This concern has little to do

with the sterility of the finished product and is relevant to sterile and non-sterile manufacture alike.
Minimization of Cleaning
Material Residual Contamination
Validation of cleaning procedures is essential to
demonstrate not only that the cleaning procedure
effectively cleans and sanitizes the manufacturing
equipment, but also that residual cleaning material
is removed to prevent contamination of the next
batch manufactured.
DANGER SIGNS IN CONTAMINATION CONTROL
Compliance professionals must be vigilant in terms
of contamination control. Contamination control is
a sure area of regulatory enforcement interest and
one where the short-sighted might be tempted to
institute cost-savings. Frequent manifestations of
cost savings
assaving mentality
ntalit deal
eal with
wit validation
lida
pectsthe
qualifications
sthe sanitizer
itizer aand cleaning
lea
quali
ions in
particular
temptation is real
p
icular can
c be expensive.
exp
e. Thee temptat
back
full pr
program. Some examples
tto pull
u bac
k from
om a fu
off these
include
the aapproaches
pr aches inc
ude accepting without confirmation bioburden information on incomingg raw
materials,
m
mat
atterriials, assuming
a su
su
um
min
ng efficacy
efficacccyy of sanitizers,
san
nitizzers,, neglectneeglecct
ing to
t cl
clean floors and other non-product contact
surfaces (especially in non-sterile production), and
other relatively high-cost overhead activities.
These are not optional safeguards to be ignored
with impunity, as several companies have recently
come to realize (10-15).
A second major area to be constantly examining
is in the general topic of consistency. A well-constructed contamination control plan will include
reasons for various activities. For example, if you
require facility scrubs in a non-sterile production,
there is a reason for this that should be described.
Requiring all operators to be in scrubs and booties is not consistent with allowing maintenance
personnel to enter the area in boots, denims, and
flannel shirt for a quick signature on a work order.
Likewise, requiring shoe covers (booties) to protect
against tracking soil organisms through the facility
is not effective if operators fail to change the booAutumn 2011 Volume 15 Number 4

63

MICROBIOLO GY TO PIC S

ties during the day (i.e., entering, leaving, going to

lunch, using the restroom, walking in them until
they hang in tatters from their ankles). Consistency
is key.
REFERENCES
1.

Oji, RT, Regulatory Aspects Concerning the Quality

Controls of Microbiological and Non-viable Particulate
Contamination in Pharmaceutical Manufacturing, Amer
Pharm Rev. 7(1):18,20,22,68, 2004.
2. Prince, H. and Prince, D., Contamination Control: The Life
and Death of Bacteria and Other Germs, Contract Pharma,
pp.2 7, June 2005.
3. Schleh, M., et al., Effectiveness of Upstream Barrier Technologies for Inactivation of Adventitious Contaminants of
Cell Culture, Amer Pharm Rev 13(7):72-76, 2010.
4. Sartain, E. & J. Polarine, Prevention of Microbial Contamination, Pharm
Technol. 35(6):62-65, 2011.
P
5. Sutton, S.,
S Successful Microbiological Investigations, Amer
Pharm
Rev. 74(2):34-42,
m Re
34-4 2011..
6. Sutton,
Environmental
Program In a
Suttoon, S., The

Environ
al Monitoring
Monito
GMP
GXP Compliance,
2010.
GM
MP Environment,
En
men J GX
ompliance 14(3):22-30,
:22010.
7. Sutton,
SVW and
Su
ut
d AM
A Cundell,
Cun l, Microbial
icrob al Identification
Ide ic
n in
the Pharmaceutical
ical Industry,
ndust y, Pharm
P rm Forum.
F rum. 30(5):18840(5): 8841894,, 2004.
8. Sutton,
SOP
Sutton, S., Thee Importance
Su
Impoortance
nc of a Strong
St
SOP System
Sy tem
m in thee
QC Microbiology Lab, J GXP C
Compliance. 14(2):44-52,
2010.
9. Martinez, J., The Rotation of Disinfectants Principle: True
or False? Pharm Technol. 33(2):58 71, 2009.
10. Sutton, SVW., Disinfectant Rotation-A Microbiologists
View, Controlled Environ., pp. 9-14, July 2005.
11. Donald, T., Vaccines Pulled Due to Potential Contamination, Contamination Control. 4(1):12 13, 2008.
12. Suvarna, K., et al., Case Studies of Microbial Contamination in Biologic Product Manufacturing, Amer Pharm Rev.
14(1):50-56, 2011.

64

Journal of GXP Compliance

13. Macdonald, G., Tabletting delay caused lethal allopurinol

contamination, say HK chiefs, Decision News Media, 2009.
http://www.in-pharmatechnologist.com/content/view/
print/239189
14. Yang, C., et al., Nosocomial Outbreak of Two Strains of
Burkholderia cepacia Caused by Contaminated Heparin
(Letters to the Editor), Hosp Infect Soc. 69(4):398 400,
2008.
15. FDA. FDA acts to prevent contamination problems with
Triad antiseptic products, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249706.htm
GXP

ARTICLE ACRONYM LISTING

API
CFU
CGMP
EM
FDA
FMEA
A
GMPss
MCTA
M
A
SOP
OP

Active Pharmaceutical Ingredient

Colony Forming Units
Current Good Manufacturing Practice
Environmental Monitoring
US Food and Drug Administration
Failure Mode Effects
Analysis
Fa
fects A
sis
Good Manufacturing
Go
Manufa
ng Practices
tices
Microbial
Content Te
Test Agar
(Soybean
Casein
Mi
ial Con
gar (Soyb
n Casei
Digest
Agar w
with Lecithin)
D
ge Ag
Standard
Operating
S
an ard Opera
ing Procedure

ABOUT
AB
A
BO
B
OUTT THE
OU
THE AUTHOR
TH
AUTH
U HO R
Scott
ott Sutton
tto is the
h founder
d and principal consultant
l
off Microbiology Network, Inc (http://bit.ly/n62yFG). He is a recognized
consultant and trainer with emphasis in GMP, investigations,
environmental monitoring, and contamination control as
well as microbiology laboratory audits and operations. He
may be reached at scott.sutton@microbiol.org or by phone at
1.585.594.8273.