Geissier - and - Boenigk - 2012 IFTS Troubleshooting

An Overview of Root Causes and Troubleshooting
Procedures for Spoilage Diagnosis
IFTPS Meeting 2012

San Antonio, Texas, USA
Hanno Geissler, SIG Combibloc, Germany

Boris Boenigk, SIG Combibloc, USA
IFTPS 2012 | An Overview of Root Causes and Troubleshooting Procedures for Spoilage Diagnosis | 03/2010 | Page 1
Topics
1. SIG Combibloc
2. Standard procedures
3
3. Real life conditions - From case to cause
4. Conclusions – How to solve issues
Topics
1. SIG Combibloc
3 Real life conditions - From case to cause
3.
The world
of packaging
Th Rank
The R k Group
G
Our parent company
Rank Group
z Private company based in New Zealand,
wholly owned by Graeme Hart
z Extensive operating experience as evidenced by highly
successful 20+ year investment track record
z Current and past Rank investments include:
SIG Combibloc
The Combibloc System
Production Filling
Shipment
Cutting Longitudinal
Coating
g
h t ) Sealing
(i sheets)
(in S li
Printing
Combibloc
„Sleeve
System“
Sleeves Base H2O2- Top
activation sterilization Filling forming
Sleeve feeding Base folding Pre Drying Ultrasonic
and forming and pressing heating
PE PE ALPE top sealing
Paperboard
What we do today
Aseptic filling technology for a wide range of products
NCSD LD Food
z Juices, nectars & still z Milk and milk drinks z Tomato products
drinks z Soy drinks z Soups
z RTD tea & coffee drinks z Cream z Cooking sauces
z Water z C d
Condensed
d milk
ilk z Baby food
z Wine & others z Drinks with particulates z Desserts
z Drinks with particulates z Other food products
Added-value services to customize filling process: product concepts, projecting,

microbiological consultancy, test filling, service support and more
For whom we perform
Leading NCSD customers worldwide
For whom we perform
Leading liquid dairy customers worldwide
For whom we perform
Leading food industry customers worldwide
Topics
1. SIG Combibloc
3
We make you fly
Custom made and safe
Reliable
technology
¾ Development
¾ Manufacturing
¾ Commissioning
¾ Change management
SIG Combibloc development process
Global Marketing & TMT

Business Technology Secretary Idea
preparation
Development Management Team
Activity Group: Activity Group:

Activity Group:
Æ Innovation / Æ System
Activity Group:
Æ Basic research
application Æ Cost optimization
platform development maintenance
development
AG / TMT
PMO
GT – TMT - Development process
Ideas
Idea phase Storage Feasibility phase Realization phase
Strategic Line
planning Project INTERN Project EXTERN organisation
5
Reason Develop. & Internal Project
Idea LoS Kick Concept Feasibility LoQ MF PS BP RF Prototype 0-Series SF
why? YES PLÆ P.-
P Nr.
Nr design tests end
off
IAM
QM
PM
Prototype validation
Aseptic processes - from design to realization
During design and construction During the prototype Sterile tests with milk
phase aseptic relevant machine
phase, internal test phase,
phase before delivery to the
parts and procedures are validation tests ensure Customer demonstrate
pre-tested on test rigs to ensure the efficiency of the efficiency of all
proper function in the prototype designed processes processes in combination
Prototype validation
Processes to validate
z Manual cleaning
z Automated cleaning CIP
z Machine piping and valve cluster steam sterilization
z Machine aseptic zone peroxide sterilization
z Package sterilization
z Package integrity
Sterilization methods
Machine sterilization processes to validate
Steam sterilization
Peroxide sterilization
Sterile Filling system /
air
system valve cluster
Sterile air
distribution
Aseptic zone
package sterilization
Field Qualification
Installation
Machine Delivery
Machine Installation
Connecting Machine
To Media Supplies
Electrical & Mechanical

Commissioning
Field Qualification
Qualification
Software Verification
Package
g Integrity
g y Tests
Sterile Test Runs
Sample Evaluation
Field Qualification
Release
Result Interpretation
Documentation
CB Internal Release
Action List
Commercial Production
Topics
1. SIG Combibloc
3
Hanno
From farm
to
fork
In daily business…
things go sometimes…
wrong!!
Spoilage
Containers, showing product changes caused by microbial growth, are spoiled!
z Insufficient sterilization of
z Product
z Upstream equipment or filling machine
z Package
z Recontamination of
z Upstream equipment
z Filling Machine
z Package
z Container integrity insufficient due to

z Package out of specification
z Improper sealing
z Damage of package after sealing
How to proceed
A rough roadmap
z Stop production
z Block the product
z Collect information:
z Lab
z Production
z Documents
z Maintenance records
z UHT – CIP records
z Speak with operators
z Search the beginning, not the end!

z Find the first affected package
z Start to control documents from there.
How to proceed
Strategies
z Findings from microbiology
z Growth condition, (temperature, aerobic- in-aerobic, growth speed)
z Type of flora, pure culture or mixture, changing from start to the end?
z Package information
z Package coding (to identify lot, production date and time)
z Integrity results (sealing and seam integrity, post seal damage)
z Production (records)
z UHT / Pasteurizer / Aseptic tank (installation, temperatures, barriers, start / stop)
z CIP of equipment connected (filling machines, valve clusters)
z Machine records of connected machines
z Operators
z Production records, observations
z Maintenance work before, during and after the affected production
z Adjustments made
Collect information and generate assumptions
Ask the bug
Rough bacterial identification scheme
Isolated microorganism
Nigrosin / differenciation by shape
RODS COCCI
Bacillis Micrococci
Actinomyces Staphylococci
Lactobacillus Sarcina
Pseudomonas Streptococci
Enterobacteriaceae Pediococci
GRAM STAIN CATALASE
+ - + -
Bacillus Pseudomonas Micrococci Streptococci

Actinomyces Enterobacteriaceae Staphylococci Pediococci
Lactobacillus Sarcina
Air Skin
CATALASE OXIDASE Hands
Raw milk Raw milk
+ - + -
Bacillus Lactobacillus Pseudomonas Enterobacteriaceae
Raw milk
Water Raw milk
Air Most likely sources of contamination;
Unsanitary conditions
Insufficient product Unwashed hands
sterilization Inadequate CIP have to be confirmed by other clues
Insufficient pack sterilization. from the investigation
Search the warehouse
Conclusions by trend analysis
100
Decreasing in-sterility 90
80
z Dirt inside p
product system
y or aseptic
p 70
60
area, 50
z insufficient aseptic area sterilization 40
(washing out effect) 30

20
10
0
Increasing in-sterility 100

90
80
z heating plant or sterile tank, 70
z contamination through valves, 60
50
filling station; 40
z interventions during production 30
20
10
0
Sudden high level 60
50
z event related
40
z changing
h i off bbatch,
t h
z sterile tank, 30
z product 20
10
z operative
ti errors, machine
hi ffaults
lt
0
Constant in-sterility 100
80
z high level= heating plant, sterile tank,
product preparation (like insufficient 60
soaking process with milk powder)
40
z low level= filling station (sometimes only 20

one track)
0
High Contamination rate at the beginning, 100
de-creasing by time; sometimes

80
increasing at the end
60
z CIP and sterilization problem (residues are

40
washed out, in the end increasing)
recontamination from cooling section of 20
UHT / P
Pasteurizer
t i possible
ibl
0
100
Sporadic contamination 80
60
z heating plant, intervention in production,
i t
interruptions
ti d
during
i production;
d ti 40
z valve block operations cause pressure

20
drops during production
0
Example of contamination source
Situation when arriving at customer
Lab
z The microbiological lab detected one in-sterile sample from a juice production, more
samples were tested and found positive (yeast)
z The first half of the production was found sterile, in the second half it started with a few
packages and ended with an in-sterility of 100%
Production
z During the production two filling machines
were connected to the same pasteurizer,
but only samples from the second machine
showed growth
Operators
z Both filling machines produced,
but with some stops in between
Investigation and root cause
Hypothesis
z The filling machine number 2 is the source
Action
z The whole machine was checked and overhauled
z No cause could be identified
Follow up
z During next production, a leaking backpressure valve
at the end of the line was detected and again in-sterile
packages from second machine only were found
Root cause
z The product supply from the pasteurizer was not sufficient
after restart of filling operation of one or both filling machines
machines.
During that time, under-pressure appeared after the second
filling machine. Through the leaking backpressure valve, yeasts
entered the sterile product line and infected the second
filling machine from the “backdoor”
backdoor
Lessons learned
Short term action

z The backpressure valve was repaired and the signal exchange had been adapted in a way,
that the p
product was requested
q by
y the filler before the in-feed valve opened,
p , so the
pasteurizer had enough time to raise the flow
System
y changes
g / improvements
p
z The existing UHT / pasteurizer signal exchange module on the filling machines had been
extended with several signals to send information about the amount of product required from
the upstream equipment
z The user manual and the pproject
j documents are updated
p with the necessary
y information to
calculate minimum amount of product flow needed to assure sterile overpressure in the
product supply pipes
Further examples for contamination sources
Upstream equipment
Situation
z High contamination rate found on packages
of a milk production
Lab
z Slight pH drop on packages detected, partly
coagulated
z Heat
H t resistant
i t t Bacillus
B ill could
ld b
be id
identified
tifi d
Production
z The first packages appeared after a stop of
filling action d
due
e to the switch
s itch of sterile tanks
Operators
z The filling had to be interrupted because of
low level at the filler product tank
Root cause
z Crack in pressure gauge in upstream line
z Infected chamber behind the membrane
Upstream setup
Situation
z Single packages found in-sterile in a whole
cream production
Lab
z Various pH- changes detected
z Cocci, Bacillus and other bacteria identified
Production
z Cream is filled at a temperature of 4°C
Operators
z No irregularities reported
Root cause
z Non insulated pipes on top of the magazine
result in individual, sporadic, in-sterile
cartons due to dripping condensate on the
sleeves in the magazine
Preventive maintenance
Situation
z In-sterile packages , only from one track of
the filling machine
Lab
z Various, non heat resistant bacteria
z First, only packages from one single track,
later from all tracks with 100%
Production
z Nothing reported
Operators
z Nothing reported
Root cause
z Flat sealing membrane before filling valve
was broken
z Sealing had not been changed within the
recommended interval
Preventive maintenance
Situation
z Sporadic in- sterile packages found from
various productions, mainly one track
affected
Lab
z Pseudomonas found in affected packages
Production
z Nothing reported
Operators
z Nothing special reported
Root cause
z Broken water hose for bottom guide
lubrication led to contamination of single
packages inside the aseptic chamber prior to
top sealing
Insufficient CIP
Situation
z Sporadic spoiled packages, distributed over
all tracks
Lab
z Heat resistant bacteria
Production
z Nothing reported
Operators
z Found the burned residues during monthly
inspection
Root cause
z Insufficient CIP on the end valve of the
product line, which is protected by steam
barrier during production
Human factor
Situation
z Sporadic spoiled packages, distributed over all tracks
Lab
z Mixed flora
Production
z In-sterility
In sterility started with a new lot of package material
Operators
z Stored the activation pattern - samples as defined in the
protocol
Root cause
z Not adapted temperature settings on machine control unit
ended up in leaking packages
Human factor
Situation
z Spoiled packages, blown, high rate on all tracks
Lab
L b
z Mixed flora, gram negative mesophilic bacteria
Production
z Production
P d ti iinterruption
t ti d
due tto product
d t lleakage
k outt off th
the
de-foaming section
Operators
z Sealing
S li off d
de-foaming
f i section
ti h had
dbbeen replaced
l d
Root cause
z Self made gasket with insufficient sealing properties
causeddahhuge claim
l i off iin-sterile
t il product
d t
Downstream setup
Situation
z Spoiled and damaged packages
Lab
z Mixed flora
Production
z Several stops on the conveyor belts due
to jammed packages
Operators
z Sorted the heavily damaged packages
out
Root cause
z wrong adjustment of the down line in
combination with improper sorting led to
package integrity failures
Conclusions
How to solve
issues
Topics
1. SIG Combibloc
3
Conclusions
z Food safety is first priority for SIG Combibloc and crucial for the companies success
z From the delivery of raw board to commercial production, aseptic specialists are involved in
all regarding processes
z Validation of processes starts with the design and prototype phase
z Field qualification of each installed filler at customer site is a standard procedure with
defined processes
Conclusions
z Despite all performed validation procedures and verification tests

tests, under real life production
conditions failures resulting in spoiled product can potentially occur
z SIG Combibloc has qualified personnel to support root cause analyses of spoilage and
implement solutions - close collaboration with our customer specialists is key to success
z Main drivers of spoilage are insufficient manual or automated cleaning procedures,

operational mistakes, extended production times, wrong installation setups and material
deficiencies
Collaboration is the key
Collaboration
is the key..
..to crack the

hard nuts
Conclusions – How to solve issues
z Talk to our customers

z We offer troubleshooting and investigation support
z Learn with our customers

z We use each discovered issue to learn from it
z Improve with our customers

z Solutions will get implemented quickly
z All changes will get validated and applied to future systems
Working with
us, in a nutshell
Peace
of mind
in packaging
p g g
your products
Thank you!

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An Overview of Root Causes and Troubleshooting

Procedures for Spoilage Diagnosis

IFTPS Meeting 2012

Hanno Geissler, SIG Combibloc, Germany

Added-value services to customize filling process: product concepts, projecting,

Global Marketing & TMT

Activity Group: Activity Group:

GT – TMT - Development process

z Automated cleaning CIP

z Machine piping and valve cluster steam sterilization

z Machine aseptic zone peroxide sterilization

Electrical & Mechanical

Sterile Test Runs

Containers, showing product changes caused by microbial growth, are spoiled!

z Container integrity insufficient due to

z Search the beginning, not the end!

z Start to control documents from there.

Collect information and generate assumptions

Nigrosin / differenciation by shape

GRAM STAIN CATALASE

Bacillus Pseudomonas Micrococci Streptococci

Bacillus Lactobacillus Pseudomonas Enterobacteriaceae

(washing out effect) 30

Increasing in-sterility 100

Sudden high level 60

Constant in-sterility 100

z low level= filling station (sometimes only 20

High Contamination rate at the beginning, 100

de-creasing by time; sometimes

z CIP and sterilization problem (residues are

z valve block operations cause pressure

Short term action

z Validation of processes starts with the design and prototype phase

z Despite all performed validation procedures and verification tests

z Main drivers of spoilage are insufficient manual or automated cleaning procedures,

..to crack the

z Talk to our customers

z Learn with our customers

z Improve with our customers

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