PHARMACEUTICAL

A COMPREHENSIVE
APPROACH TO CLEANING
TM
& DISINFECTION
Designed Specifically for Pharmaceutical Manufacturers
 PHARMACEUTICAL

Addressing Your Specific Needs with

Our Total Plant Solutions

The Ecolab Benefit

At Ecolab, we provide our customers CLEAN

with the support of a global
R ING
organization renowned for the most
OME PRO & DIS
effective programs combined with
UST INING GR IN
AM FE
the highest levels of service. C RA S
T

CT
◢◢ Founded in the US in 1923

IO
◢◢ Operational in over 170 countries
SAFETY

N
◢◢ Over 48,000 employees

CLE LIDATION SUPPO ION

◢◢ O
 ver 3,000,000 customers

VA
worldwide

ANING
◢◢ L
 argest sales and service force in
the industry

SURVEYS
SITE
Experienced, highly trained and backed

& DISINFECT
by the full resources of the global leader
in sanitation, our dedicated Life Sciences

NCE
EFF
team will deliver the proven solutions
customers need to:

LIA
I
CIE

RT
◢◢ P
 roduce safe, compliant products
WE ARE A TRUSTED

MP
N
that exceed your customers’

CY
PARTNER TO OVER 20

CO
standards

◢◢ C
 ontinuously and measurably
OF THE WORLD’S TOP
improve operational efficiency
PHARMACEUTICAL E
EN GUL LA

B
R
SC
◢◢ H
 elp achieve sustainability goals,
TIF ATO L

I
I C A O RT
including reducing water and MANUFACTURING
energy consumption IC RY & H N
COMPANIES. IN S
IG H T TEC SUPP
S
EXPERTISE IN LIFE SCIENCES

Our business has a strong track record
in Europe where we are leaders in the
cleaning and disinfection market for
the Pharmaceutical industry, including
partnerships with the leading global
Pharmaceutical, Biopharma and Contract
Drug Manufacturing organizations.
We provide our customers with complete cleaning and disinfection programs for external
surfaces of manufacturing equipment and cleanrooms, and for direct product contact
surfaces.
These programs meet the latest regulatory standards and our dedicated products are
manufactured in fully auditable and traceable production facilities.
With years of industry experience, our Validation and Technical Support teams will assist
you in developing and implementing the best programs for your facilities.

2 3
 PHARMACEUTICAL

Our Programmatic
Approach

Cleaning & Disinfection Programs

Ecolab provides you with site-specific cleaning and disinfection programs to help manage CIP (CLEAN IN PLACE) & COP (CLEAN OUT OF PLACE)
risk and improve process efficiency for external surfaces of manufacturing equipment and
cleanrooms, in addition to direct product contact surfaces.
Cleaning and disinfection solutions for ◢◢  comprehensive Ecolab Cleaning
A
direct product contact surfaces. Validation support web page, which has
CLEANROOMS been designed to help our customers
This program provides:
with their cleaning validation processes
◢◢  specific product range for
A or revalidation in the pharmaceutical
Cleaning and disinfection solutions for ◢◢  lant maintains full validated batch
P
the pharmaceutical industry – industry
external surfaces of manufacturing traceability and can be audited on
COSA™ Range
equipment and rooms. request ◢◢ CIP Optimization: An evaluation and
◢◢ Formulations providing high rinsability recommendation on methods to optimize
This program includes: ◢◢ Innovative packaging solutions, such
as our patented SteriShield Delivery ◢◢  o silicate, perfume, silicone
N time, temperature, mechanical action,
◢◢  terile products as part of the
S chemistry and chemistry residuals in CIP
System (SDS) on the trigger spray bottles, or coloring
Klercide™ range systems
which works as a closed system designed
◢◢  roducts manufactured to GMP quality
P
◢◢  roducts manufactured in cleanrooms
P to preserve the sterility of the contents  e offer installations for automatic
W
We go beyond
◢◢
with fully documented work instructions
using sterility assurance best practices throughout use cleaning and disinfection. After an
and procedures
to ensure sterility. This provides
the reassurance that your process
◢◢  ertificates of Analysis available for all
C
◢◢  ully validated batch traceability and can
F
assessment of your process, we are
able to recommend the equipment
identifying the right
chemical SKUs
validation is secure, using products with be audited on request installation to meet your requirements. chemistry - we develop
substantiated quality  ertificates of Analysis available for all
C These installations could cover a variety
◢◢
chemical SKUs of equipment, such as: storage stations, site-specific hygiene
pump systems, conductivity dosing
systems, CIP Kits, etc.
programs to maximize
process efficiency and
help manage risk.

KLERCIDE™ COSA™
RANGE ALKALINE CLEANERS RANGE

ACID CLEANERS
Manufactured in our state-of-the-art facility,
IO N
TO OLS R M AT S AN
T R O TAT Manufactured in a pharmaceutical GMP production facility,
FO CT
IO
our extensive range of sterile alcohols and AT T E N our comprehensive range of cleaners and additives provides
ADDITIVES/BOOSTERS
C
IC

F
DU

IN
PL

biocides provides control of contamination on READY-TO-USE

process optimization in your CIP and COP systems.
DIS
PRO
AP

TRIPLE ALCOHOLS
cleanroom surfaces. BUCKET SYSTEM MANUAL CLEANING
PRESATURATED
DISINFECTANTS
WIPES
MOP WIPE
FRAMES SPORICIDES SANITIZERS &
CONCENTRATES
DISINFECTANTS

4 5
 PHARMACEUTICAL

Global Technical Our Programmatic

Consultants Support
TECHNICAL EXPERTISE TO SUPPORT
AND ACHIEVE cGMP COMPLIANCE, DRIVE
EFFICIENCIES AND ENABLE A HARMONIZED
APPROACH ACROSS MANUFACTURING SITES
Cleaning & Disinfection Validation Support
An Ecolab partnership gives you access to experienced technical
experts that partner with you to deliver sustained compliance
and operational excellence.

Your account manager works closely with you and our skilled
technical team to tackle your unique challenges, providing
you with the best-in-class service and solutions to deliver on
your key goals – patient safety, product safety and quality,
productivity and regulatory compliance.
We assist you in navigating the complex validation processes and change
controls, through optimization based on environmental and economic targets,
and assistance with validation efficacy project management.

Our Global Technical Consultants offer:

CLEANING VALIDATION SUPPORT

This support includes: Specific and non-specific methods

available:
◢◢  aboratory testing on the most
L
From laboratory sample challenging soils ◢◢  PLC (High-Performance Liquid
H
Chromatography)
testing to site surveys, ◢◢ Toxicology Data (LD50 or PDE)
◢◢ TOC (Total Organic Carbon)
◢◢  llowable residue limit calculation
A
CLEANING & DISINFECTION you can count on Ecolab for cleaning and disinfection ◢◢ Photometric
VALIDATION SUPPORT
to help you maximize agents ◢◢ Conductivity
◢◢  alidated analytical methods
V
product quality, while for testing residues of cleaning /
◢◢ Test strips

Surface tension
driving safety, regulatory disinfection agents (ICH ◢◢

Guidelines)
compliance and
operational efficiency. VALIDATION EFFICACY PROJECT MANAGEMENT

By partnering with customers to ◢◢  review of draft reports for data

A
coordinate laboratory studies, we accuracy and alignment with
SITE SURVEYS accelerate the validation process. protocol intent
by IRCA-accredited We also provide on-site training and
◢◢  onsultation on documentation
C
SMEs guidance to assure a smooth transition
required to meet regulatory
from laboratory studies to practical,
expectations
real-world application. This includes:

◢◢  rotocol development and

P
coordination with accredited
contract testing laboratories

REGULATORY
& SCIENTIFIC
INSIGHTS

6 7
 PHARMACEUTICAL

Our Programmatic
Support

Site Surveys Regulatory & Scientific Insights

We have a service available from our International Register of Credited Auditors (IRCA)
to assess the compliance and effectiveness of your cleaning and disinfection programs.
Our expert team has knowledge ◢◢  onduct deep analysis of global
C
of the regulations and regulatory inspection trends in cleaning and
SITE SURVEYS
environment to ensure compliance disinfection (EU, US, PIC/S)
with cGMP, assure product safety
◢◢  ead the development of
L
Conducted on-site, the surveys include an ◢◢  perator safety and environmental
O and quality, and help implement
optimal methods for efficacy
in-depth analysis of cleaning and disinfection impact validations that meet regulatory
determinations, engaging with
processes to determine: expectations.
◢◢  he risks of non-compliance with
T the scientific and regulatory
◢◢  ompliance with cGMP and alignment
C emerging standards community to drive acceptance
We:
with inspection expectations  upport customer validation
S
Following the site survey, a detailed report ◢◢  ontinuously survey the
C
◢◢
◢◢  pportunities for improvement, cost
O provides site and consolidated findings implementation that meets
regulatory landscape for
savings and complexity reduction together with preliminary recommendations regulatory expectations
changes in cGMP requirements
to help you prioritize your opportunities for and standards for cleaning and
improvement. disinfection

Technical Lab Support

Ecolab offers support to identify the Testing may include:

right cleaning procedure for your
1. S
 oil removal studies on your most
specific processes and products.
challenging soils

2. Studies
 to assess product
THE COMPREHENSIVE SITE REVIEW SERVICE
compatibility with customer
surface materials
Provided by accredited (IRCA) subject matter experts
3. P
 erformance analysis to compare
experienced in offering technical support and regulatory
procedures and techniques
guidance to pharmaceutical facilities.
4. R
 esidue analysis for customer
surfaces to help determine
changes required

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 PHARMACEUTICAL

Our Programmatic Dedicated Resources at the

Support Corporate and Local Level

Our customers are at the center

of all we do. From customized
Customer Training cleaning and disinfection ACCOUNT MANAGER
programs to validation support
and beyond, our global account
◢◢ Connects routinely with your local teams
management team partners
with you to create customized ◢◢ Ensures alignment on plant drivers and KPIs
solutions that meet your needs ◢◢ R
 eviews cleaning and disinfection programs for
and exceed your plant goals. the facility
We achieve this by working closely ◢◢ Identifies opportunities and provides recommendations
with you at both the local plant
◢◢ Executes continuous improvement projects
and corporate level to design and
provide a consistent approach ◢◢ P
 rovides you with our full suite of service standards
for your facilities that unifies our called Six Star Services
Ecolab resources and expertise
◢◢ Trains plant employees
to deliver what you need to be
successful.

Our technical teams conduct on-site Our comprehensive training covers a variety of topics such as those listed below:
training programs to ensure that best
◢◢ Optimal cleaning and disinfection application techniques
practices are understood and implemented
correctly to meet the quality and safety ◢◢ Safety training
standards at customer facilities. ◢◢ Regulatory requirements and standards

◢◢ CIP optimization

◢◢ Validation guidance CORPORATE ACCOUNT MANAGER

We also organize and participate in various industry seminars to educate the industry as well as
define and improve regulatory standards to achieve optimal process solutions and outcomes. ◢◢ Connects with customers at corporate level

◢◢ Manages performance KPIs and escalations

◢◢ Drives best practices and portfolio standardization

◢◢ A
 ccelerates progress towards continuous
improvement opportunities

◢◢ Drives value delivery

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 OUR ASS URA NCE

Ecolab is committed to providing exceptional service, total plant solutions and

unsurpassed industry expertise to help you achieve your business goals.

Our breadth of resources and integrated business model ensure consistency across
your operations. We look forward to the opportunity to partner with you on your
transformation journey.

PLEASE SPEAK TO YOUR ECOLAB ACCOUNT MANAGER FOR FURTHER INFORMATION

WORLDWIDE
WORLDWIDE HEADQUARTERS
HEADQUARTERS
1 Ecolab
1 Ecolab PlacePlace
St. Paul,
St. Paul, MN 55102
MN 55102
USAUSA
www.ecolab.com/lifesciences
www.ecolab.com/lifesciences
www.ecolab.com/pharmaceutical
www.ecolab.com/pharmaceutical
9448.3

© 2018 Ecolab USA Inc. All rights reserved. 06APR18/NA