DEEP UNDERSTANDING

UHT OPERATION
(Thermal processing, Contamination, and Risk of High Resistent Spora)

By Asep Noor

Dedicated for internal only

PT INDOLAKTO
Content of Workshop
History of UHT Processing
Principle of Aseptic Processing
Definition related to Thermal Processing
High Resisten Spore (HRS) in UHT
•Definition of HRS
•Possibility of HRS Contamination
•Source of HRS Contamination
•Technical Solution

Quality Control in UHT

•Raw material
•In process inspection
•Post contamination
•How to detect HRS

•Workshop session
•Indolakto performance of sterility : AQL Figure, Complain Figure, Contamintation Figure
•Exercise to calculate sterility
•Improve wrong in UHT operation
•Case study from 2010-2013
•Action Plan to increasing performance and minimizing HRS risk

References

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 History of UHT Processing
• Sejarah pengawetan pangan dimulai ketika Louis Pasteur menemukan proses
pemanasan yang dikenal dengan proses pasteurisasi

• Dilanjutkan dengan Nicholas Appert yang melakukan pengawetan makanan

dengan proses pengalengan dan pemanasan

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 History of UHT Processing

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 Principle of Aseptic Processing

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 Principle of Aseptic Processing

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 Definition in Aseptic Processing

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 Definition in Aseptic Processing

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 Key number in Aseptic Processing

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 What the HRS Definition

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 What the HRS Definition

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 What the HRS Definition

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 What the HRS Definition

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 Possibility of HRS Contamination

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 Heating Methods to eliminate HRS

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 Infussion System

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 Raw Material & Quality Control of UHT

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 Raw Material & Quality Control of UHT

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 Raw Material & Quality Control of UHT

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 Raw Material & Quality Control of UHT

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 Product Testing – Quality of UHT

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 Quality Control of UHT

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 Quality Control of UHT

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 Quality Control of UHT

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 Quality Control of UHT

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 Quality Control of UHT

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 How to Detect B. sporothermudurans

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 Indolakto History HRS Contamination

Acceptance Quality Level

UHT 125 ml UHT 200 ml UHT 1000 ml Total UHT
Year
AQL Freq AQL Freq AQL Freq AQL Freq
2008 0,05% 64 0,15% 37 0,15% 6 0,06% 107
2009 0,01% 11 0,04% 8 0,09% 2 0,02% 21
2010 0,05% 63 0,04% 12 0,50% 21 0,06% 96
2011 0,04% 103 0,09% 52 0,19% 20 0,05% 175
2012 0,04% 72 0,08% 36 0,21% 16 0,05% 124
2013 0,08% 270 0,08% 60 0,40% 60 0,08% 390

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 Indolakto History HRS Contamination

Acceptance Quality Level

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 Indolakto History HRS Contamination

Acceptance Quality Level (include custommer complain)

UHT 125 ml UHT 200 ml UHT 1000 ml Total UHT
Year
AQL Freq AQL Freq AQL Freq AQL Freq
2008 0,08 104 0,20 52 0,70 44 0,11 200
2009 0,05 54 0,11 33 0,53 29 0,07 116
2010 0,08 96 0,08 31 1,62 82 0,12 209
2011 0,06 144 0,11 76 0,54 69 0,08 289
2012 0,05 98 0,10 46 0,45 41 0,07 185
2013 0,09 290 0,10 71 0,47 72 0,10 433

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 Indolakto History HRS Contamination

Acceptance Quality Level (include custommer complain)

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 Indolakto History HRS Contamination
Contamination Figur
UHT 125 ml UHT 200 ml UHT 1000 ml Total UHT
Year
Survivor Post Cont. Survivor Post Cont. Survivor Post Cont. Survivor Post Cont.
2008
2009
2010
2011
2012 85 236 9 44 2 27 96 307
2013 68 210 18 34 10 37 96 281

Customer Complain Dari AQL

UHT UHT UHT
Year Total
125 ml 200 ml 1000 ml
2008 40 15 38 93
2009 43 25 27 95
2010 33 19 61 113
2011 41 22 49 112
2012 26 10 25 61
2013 20 11 12 53

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 Highlighted Microbiology Case

Tahun 2011
Nov : HRS ditemukan di Line A
Des : HRS ditemukan di line UHT 125 ml

Tahun 2012
Mei : Produk Ex Line J Koagulasi (Unproper CIP)
Aug : HRS ditemukan di line UHT 125 ml

Tahun 2013
Jan : Produk Ex Line M Koagulasi (Unproper CIP)
Sep : Produk Ex Line M Koagulasi (Unproper CIP)

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 How to exam Heating Sufficiency
KONDISI STANDAR / ACUAN

  Tref 185 oF
Name,
  D185 0,5 menit Name of Acidity in final Preserv.
Form or Critical raw
Raw sterilizer Heating Max Acidifyin product as and
Pasteurisasi Z 16 oF No Style and material
pH (MFR & medium Eql. pH g agent acetic acid conc.
  Siklus 5   Packing (pH>4.6)
TYPE) (%w/w) (%w/w)
  Fo 2,5 menit medium

1 UHT Plain Milk 6,7 PHE Water 3.6+0.1 N/A N/A None
  Tref 250 oF
  D250 0,25 menit UHT
2 Milk 6,7 PHE Water 4.5+0.3 N/A N/A None
Sterilisasi Z 18 oF Choco
  Siklus 12   UHT
3 Milk 6,7 PHE Water 4.5+0.3 N/A N/A None
  Fo 3 menit Choco

Rheological properties Sterilizer performance

Solid to
%solid Thermal Container Inside Min
liquid Food Density
(CEM Aw process type and Consistenc Flow
Diam. of
Length of
initial
Debit
V
ratio category (g/ml)
method) required capacity y Index (K) behaviour Note
holding
holding
temp.
max
(cm/sec)
(oBrix) (Pa.S) index (n) tube (cm) (L/hr)
tube (cm) (oC)
Glass
Non-Newtonian
18 42+2 0,918 Acidified Pasteurization 1,1 bottle 315 47,4 0,267 8,22 426 28 5000 26,19
(pseudoplastic)
ml
Commercial Carton Non-Newtonian
18 21,9 0,900 Low-acid 1,19 12,8 0,484 8,22 426 28 10000 52,37
sterilization Pack (pseudoplastic)
Commercial Carton Non-Newtonian
18 21,9 0,900 Low-acid 1,19 12,8 0,484 8,22 426 28 10000 52,37
sterilization Pack (pseudoplastic)

 
Processing temp (oF)
  Residence time of
V max F = L217.4*t
the fastest moving Tref (oF) Z (oF) L217.4 Rekomendasi
Reynolds Flow (cm/sec) (minute)
particle (t, sec) Setting Max Min
number (Re) category

Proses pasteurisasi
46,6 Laminar 37,22 11,45 221 230 217,4 185 16 105,9 20,2
mencukupi
Proses sterilisasi tidak
271,4 Laminar 86,53 4,92 221 230 217,4 250 18 0,015 0,001
mencukupi
Proses sterilisasi tidak
271,4 Laminar 86,53 4,92 221 230 217,4 250 18 0,015 0,001
mencukupi

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 Preventive and Corrective to handle HRS
5M Key Problem Key Preventive Action to be establish
Worker Skill

Awareness

Machine Process
Filling

CIP Unit

Methode Operational
Procedure Production
Maintenance
Inspection
Validation
and
verification

Material Fresh Milk

Cocoa
powder
Rework

Environment Fresh Milk

Cocoa
powder
Rework

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 Wrong Operation

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 Wrong Operation

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 Result Test HRS 2012

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 Result Test HRS 2012 from Tetrapak

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 Case Study Unsteril UHT 1000 ml

• Three production code was affected in 2011

• A030512 was packed on 3-4 August and used chocolate milk
A040512 was packed on 4-5 August and used chocolate milk
B060512 was packed on 7 August 2011 and used plain milk
• A030512 is the first production after idle for 2 months
• Defect type for A030512 and A040512 is low pH (5.92-6.2)
• Re-sampling and Microbiology analysis had been done.
Spoilage of A030512 and A040512 caused by gram negative
bacteria

NN/MMYY
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 Spoiled Pack

• A040512 (low pH, soft coagulated, and sour smell)

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 Defect Pattern on August 3 2011 CFA1D0300A

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 Defect Pattern on August 4 2011 CFA1D0300A

or Time 0000H 0100H 0200H 0300H 0400H 0500H 0600H 0700H 0800H 0900H 1000H 1100H 1200H 1300H 1400H 1500H 1600H 1700H 1800H 1900H 2000H 2100H 2200H 2300H
Sterilization/UHT?

Aseptic tank

Volume @: '00 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200
Volume @: '30 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500

Machine #1 Start:15:37 20:15-20:20

22:53-1:50 1:50-04:10 16:38 17:26 '18:30 19:30 20:5022:22 23:35-00:24
Normal stop 4:20 5:10 6:02 6:53-7:33 16:08 17:05 17:50 18:40 20:00 22:10 23:00
PM change PM: 15:58 PM:20:17 PM:22:39
Strip change SS:17:26 TS:22:22SS

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 Defect Pattern on August 4 2011 CFA1D0400A
color Tim e 0000H 0100H 0200H 0300H 0400H 0500H 0600H 0700H 0800H
terilization/UHT?
Mi Mi

Aseptic tank
L O
Volum e @: '00 1200 1200 1200 1200 1200 1200 1200
Volum e @: '30 1500 1500 1500 1500 1500 1500 1500

Machine #1
Servic Start:00:47 1:14-1:20 2:40-2:47 4:10 End :7:23
Norm al s top NS:1:00 3:35 5:10-5:16 6:30-6:48
PM change PS 5:19 PS:7:20
Strip change SS:5:16

Paper jammed on dancing roller and

sensor on dancing roller is detached,
paper breaks and splice manually

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 Defect Pattern on August 5 2011 CFA1D0400A
No color Time 0000H 0100H 0200H 0300H 0400H 0500H 0600H 0700H 0800H 0900H 1000H 1100H 1200H 1300H
Sterilization/UHT?
Mi Mix1

Aseptic tank
L Ok
Volume @: '00 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200
Volume @: '30 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500 1500

Machine #1 Start:4:47 5:255:53 6:40 End:12:15

Service 8:10 10:57
Normal stop NS:5:05 5:35 6:17 7:42
PM change PM:7:18 PM:9:13 PM:11:35
Strip change SA:6:57 SA:10:02

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 Description
A030512
Defect was found during normal production (random sample) and always
after an event
•Re-start after normal and short stop
•After packaging material splicing
•After strip splicing

A040512
Defect was found always after an event (re-start after normal stop and
paper & strip splicing) and during normal production (random sample )

The defect pattern are single peak or irregular peaks with wash out effect

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 Hypotesis
• Tube Integrity
NMD
o Paper twisted
o Splicing paper
NMD
o LS Short stop element
• Package Integrity
• System Tightness
o Wrong/ broken gasket
NMD
o Pin holes
• Weak CIP (Product residue) NMD

• Incorrect Over and Under pressure of aseptic chamber

NMD
• Worn out TS component (dollies, Inductor, etc)
• Personnel hygiene

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 Package Integrity
• Red ink penetration less than 1 mm encountered on bottom and top
of upper heat pattern
• TS fold was noticed intermittently on fin corner which cause bending
off almost touch ridge

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 Packaging Material Splicing

LS Blocked seal on
area which attached
by tape

• Packaging material splicing was done manually

(using tape). On area which is attached by tape,
overlap and LS strip is detached.
• This action resulted in open tube and re-infection
from chilled water

Detached overlap

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 Packaging Material Splicing

Improving ASU and splicing paper automatically

•Splicing paper automatically without tape and followed by short stop
Overlap sealing paper width = 10 mm with good seal
Sealing alignment = 1 mm
Small part of overlap besides double layer paper detached
LS strip was detached on double paper area
Little product leak through spliced area after pressure test
Other reject packs have good seal of SA/LS strip and no product leakage after pressure
test

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 Packaging Material Splicing
• Splicing paper automatically without tape
and followed by short stop
No product leakage detected after pressure test
LS Good seal on double layer packaging
material
Small part of overlap besides double layer
paper detached
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• Splicing packaging material without short stop
Overlap sealing paper width = 10 mm with good seal
Sealing alignment = 1 mm
Small part of overlap besides double layer paper
detached
LS strip was detached on double paper area
Little product leak through spliced area after pressure
test
 Installation
TA Flex line 2 Alsafe line 2

Line A- TBA/8
1000 ml
6000 packs/hour

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 Valve A & Valve C
Product residue Product residue on
found on valve A Valve C
and valve A
housing

Broken gasket

Residue on
clamp ring of
Valve C

Notes : Photo was taken after CIP

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 Aseptic Line
Until 15 August 2011, During weekly care on Product residue also detected on clamp ring
Sensor level (connection September 23, 2011,
from AT2 to TBA/8 line A product residue was
use wrong gasket). Gasket sticking onto sensor level.
have already broken when
clamp ring was opened.

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 Aseptic Line
• Product residue also noticed on pipe connection from aseptic tank to filling
machine (valve A)

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 TS Component (Left Jaw)

Inductor corrosion

Damaged Inductor

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 TS Component
(Right Jaw)

Inductor corrosion

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 Additional data Unsterile B060512
Based on Production record on August 2011, problems encountered on TBA/8 line A:
•Packaging material splicing always done manually using tape
•Paper twisted occurred after packaging material splicing which caused paper breaks on aseptic chamber
•After re-start or start of production, paper is out of track (cause open tube)
•Edge weaking detected during re-start after short or normal stop

No color Time 0700H 0800H 0900H 1000H 1100H 1200H 1300H 1400H 1500H 1600H 1700H 1800H 1900H 2000H 2100H 2200H 2300H
Sterilization/UHT?
Mi Mix1

Aseptic tank
L Ok
Volume @: '00 1200 1200 1200 1200 1200 1200
Volume @: '30 1500 1500 1500 1500 1500 1500

Machine #1
Service Start :6:54 10:35 11:28 13:55 19:00-19:05
Normal stop 7:30 11:10 12:05 13:10 13:50 14:45 16:45 20:24-20:3020:53-21:13
PM change PS:7:46 PS:9:15 PS 11:56 PS14:10 PS 16:30 PS 19:55 PS 22:28
Strip change SS:9:02 SS:13:30 SS 17:45 SA: 22:51

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 Unsterile B060512
 Defect was found during normal production (random sample) and
after an event
• Re-start after normal and short stop
• After packaging material splicing (always)
• After strip splicing

 Defect packs were found mostly in the beginning and end of

production

 Spoilage of B060512 caused by Bacillus cereus

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 Hypotesis
• System Tightness
o Wrong/ broken gasket
o Pin holes
• Weak CIP (Product residue)

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 Investigation result
• 17:43-18:57 normal stop for break fasting, machine was stop more than 40
minutes and no inching records during stop
• During Production, paper often jammed in Bending Roller ASU
• On 22:00-22:38 Packaging material breaks in Tab applicator
• Package Integrity:
 Red ink penetration less than 1 mm encountered on bottom and top of upper heat
pattern
 TS fold was noticed intermittently on fin corner which cause bending off almost
touch ridge
• ABC Valve :
 Product residues were found on valve A and valve A housing
 Gasket on C-valve is broken
 Product residue were found on C-valve and C-valve clamp ring

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 Investigation result
Aseptic lines:
 Until 15 August 2011, Sensor level (connection from AT2 to TBA/8 line A use
wrong gasket). Moreover, gasket have already broken when clamp ring was
opened.
 During weekly care on September 23, 2011, product residue was sticking
onto sensor level
 Product residue was found on clamp ring of sensor level
 Product residue also noticed on pipe connection from aseptic tank to filling
machine (valve A)
 Product residue also found on end valve cluster

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 References

05/11/20
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 TERIMA KASIH
ATAS PERHATIAN DAN INPUTNYA

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