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Qualification Documentation (Q-doc)

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. ky Alfa Laval TJ SaniJet 20 Rotary Jet Head Meets the Highest Standards in Hygienic Cleaning . Application The device is designed for use in pharmaceutical, biotechnological, food and dairy processing applications and is suitable for tanks and vessels between 0.5 and 30 m 3 . It is especially well-suited to processing highly viscous, foaming or thixotropic products and to chemical processing applications where product cross-contamination is unacceptable. Working principle The Toftejorg SaniJet 20 is a hygienic, rotary jet head device that cleans in a 3D indexed “Golden Sectionpattern. It has an integrated self-cleaning (patent pending) and self-draining downpipe. The drive mechanism is located outside the tank, leaving a minimum of parts inside the vessel or to be submerged into the product. The distance between the tracks of the jets ensures efficient removal of residual product from the tank surface, from the start of the cleaning sequence, allowing for quick jet effective cleaning. TECHNICAL DATA Lubricant: ................... Machine: Self-lubricating with the cleaning fluid Air motor: Can operate non-lubricated Surface finish: Product contact parts: ........... Ra 0.8μm Impact throw length: ............ 1.5 - 4 m Min. tank opening: ............. 4Clamp w. rotacheck 3clamp - rotacheck N/A Pressure CIP media working pressure: ...... 3-13 bar CIP media recommended pressure: . . 5-8 bar Air driven Air quality: Clean, filtered max. ............. 40μm Dry, dew point max.: ............ 5°C Non-lubricated possible Air supply pressure: ............ max. 7 bar Free air consumption: ........... Max. 2 l/sec. (8 m 3 /h) Adjustable speed: .............. 5 - 16 RPM Cleaning time: ................ 3 - 10 min Certificates 2.2 material certificate, Q-doc, Q-doc incl. FAT & SAT and ATEX. PHYSICAL DATA Materials 316L (UNS S31603), PEEK*, Sealing: EPDM* (standard), FPM* FFKM* * FDA compliance 21CFR§177 Temperature Max. working temperature: ........ 90°C Max. ambient temperature: ........ 140°C Weight Media-driven machine: ........... 11 - 18 kg Air-driven machine: ............. 11.7 - 19.2 kg Connections Inlet connection: ............... Clamp: 1ISO 2852 Tank connection: .............. Clamp: 4ISO 2852 Tank connection: .............. Clamp: 3ISO 2852 Note: 3Tank connection has no possibbility of integrated rotacheck. Options A. Electronic rotation sensor to verify 3D coverage B. Improved surface finish C. 3.1 certification for metallic parts by request D. With FFKM or FPM seal ring E. ATEX Caution Avoid hard and abrasive particles in the cleaning liquid, as this can cause increased wear and/or damage of internal mechanisms. In general, it is recommended to place a filter in the supply line.
Transcript
Page 1: Qualification Documentation (Q-doc)

.

kyAlfa Laval TJ SaniJet 20 Rotary Jet Head

Meets the Highest Standards in Hygienic Cleaning

.

ApplicationThe device is designed for use in pharmaceutical, biotechnological,food and dairy processing applications and is suitable for tanksand vessels between 0.5 and 30 m3. It is especially well-suited toprocessing highly viscous, foaming or thixotropic products and tochemical processing applications where product cross-contaminationis unacceptable.

Working principleThe Toftejorg SaniJet 20 is a hygienic, rotary jet head device thatcleans in a 3D indexed “Golden Section” pattern. It has an integratedself-cleaning (patent pending) and self-draining downpipe. The drivemechanism is located outside the tank, leaving a minimum of partsinside the vessel or to be submerged into the product. The distancebetween the tracks of the jets ensures efficient removal of residualproduct from the tank surface, from the start of the cleaning sequence,allowing for quick jet effective cleaning.

TECHNICAL DATA

Lubricant: . . . . . . . . . . . . . . . . . . . Machine: Self-lubricatingwith the cleaning fluidAir motor: Can operatenon-lubricated

Surface finish:Product contact parts: . . . . . . . . . . . Ra 0.8µmImpact throw length: . . . . . . . . . . . . 1.5 - 4 mMin. tank opening: . . . . . . . . . . . . . 4” Clamp w. rotacheck

3” clamp - rotacheck N/A

PressureCIP media working pressure: . . . . . . 3-13 barCIP media recommended pressure: . . 5-8 bar

Air drivenAir quality:Clean, filtered max. . . . . . . . . . . . . . 40µmDry, dew point max.: . . . . . . . . . . . . 5°C Non-lubricated possibleAir supply pressure: . . . . . . . . . . . . max. 7 barFree air consumption: . . . . . . . . . . . Max. 2 l/sec. (8 m3/h)Adjustable speed: . . . . . . . . . . . . . . 5 - 16 RPMCleaning time: . . . . . . . . . . . . . . . . 3 - 10 min

Certificates

2.2 material certificate, Q-doc, Q-doc incl. FAT & SAT and ATEX.

PHYSICAL DATA

Materials316L (UNS S31603), PEEK*,Sealing: EPDM* (standard), FPM* FFKM** FDA compliance 21CFR§177

TemperatureMax. working temperature: . . . . . . . . 90°CMax. ambient temperature: . . . . . . . . 140°C

WeightMedia-driven machine: . . . . . . . . . . . 11 - 18 kgAir-driven machine: . . . . . . . . . . . . . 11.7 - 19.2 kg

ConnectionsInlet connection: . . . . . . . . . . . . . . . Clamp: 1” ISO 2852Tank connection: . . . . . . . . . . . . . . Clamp: 4” ISO 2852Tank connection: . . . . . . . . . . . . . . Clamp: 3” ISO 2852Note: 3” Tank connection has no possibbility of integrated rotacheck.

OptionsA. Electronic rotation sensor to verify 3D coverageB. Improved surface finishC. 3.1 certification for metallic parts by requestD. With FFKM or FPM seal ringE. ATEX

CautionAvoid hard and abrasive particles in the cleaning liquid, as this cancause increased wear and/or damage of internal mechanisms. Ingeneral, it is recommended to place a filter in the supply line.

Page 2: Qualification Documentation (Q-doc)

Standard DesignThe Toftejorg SaniJet 20 is available in media-driven or air-drivenversion. Air-driven versions are equipped with a magnetic clutch forleakage-proof transmission. The air motor provides an effective drivefor low flow machines in rough environments and for use in explosivehazard zones, provided it is installed according to safety instructions.The air motor has variable speed to adjust cleaning intensity. Thehygienic construction of the Toftejorg SaniJet 20 is designed, withthe aim to meet regulations, such as EHEDG, etc. As standarddocumentation, it can be supplied with a "Declaration of Conformity"for material specifications. ATEX approved, Category 1 for installationin zone 0/20.

Cleaning PatternExample - 2xø3.8LS

0.8 min. 2.3 min. 6.0 min.

Qualification Documentation (Q-doc)Designed for the BioPharm and Personal Care industry for qualificationof hygienic Tank Cleaning Machines. Developed in according tothe ISPE V-model and GDP, Good Documentation Practice, andincludes: RS (Requirement Specification); DS (Design Specificationincl. Traceability Matrix); FAT (Factory Acceptance Test incl. IQ & OQ);3.1 and USP Class VI Certificates; FDA Declaration of Conformity; TSEDeclaration; QC Declaration of Conformity; SAT (Site Acceptance TestProtocol incl. IQ & OQ) for End-User Execution.

Documentation specificationEquipment Documentation includes:

Q-doc

- EN 10204 type 3.1 Material Inspection certificate- USP Class VI certificate- FDA Declaration of Conformity- TSE Declaration- QC Declaration of Conformity

ATEX approved machine for use in explosive atmospheres.Media driven version:

Catagory 1 for installation in zone 0/20 in accordance to

Ex II 1 GD c T 140°C.

Air driven version:

Catagory 1 for installation in zone 0/20 in accordance to

Ex II 1 GD c T140°C.

Air driven unit:

Catagory 2 for installation in zone 1/21 in accordance to

Ex II 2 GD c IIC T4 Tamb -20°C to +40°C

ATEX

Qualification Documentation includes:

Q-doc +

FAT-SAT

- Q-doc: 3.1 , USP Class VI, FDA, TSE and QCDeclaration of Conformity

- RS, Requirement Specification- DS, Design specification incl. Traceability Matrix- FAT, Factory acceptance Test incl. IQ and OQ- SAT, Site Acceptance Test protocol incl. IQ and OQ

for End-User Execution

Page 3: Qualification Documentation (Q-doc)

Flow Rate (Media & Air driven)

Flow Rate Impact Throw Length, Media DrivenNozzles mm Nozzles mm

Flow rate

m3/h

9

8

7

6

5

4

3

2

1

2 3 4 5 6 7 8 9 10 11 12 bar

4xø4.2

2xø3.8

2xø2.0

LS

13

4107

-000

0

Throw length

m

8

7

6

5

4

3

2

1

2 3 4 5 6 7 8 9 10 11 12 bar13

4107

-000

1

4xø4.2

2xø3.8LS

2xø2

Inlet pressure Inlet pressureRecommended operating pressure: 5-8 bar

Page 4: Qualification Documentation (Q-doc)

Dimensions (mm), Media Driven Cleaning Time, Complete Pattern, Media drivenMin. RPM of machine body Nozzles mmPTM (Pattern time minutes)

537

- 687

- 88

7 - 1

187

- 138

7 - 1

687

350

- 500

- 70

0 - 1

000

- 120

0 - 1

500

31

112.5

Ø11

9

Ø69

OPTION:RotacheckSensor

4” ClampISO2852

Ø119

132

157.

25

17272

23

1” ClampISO2852

41070144 5

6

15

20

7

89

1113

15

5

3

2

2 3 4 5 6 7 8 9 10 11 12 bar13

4107

-000

3

2xø2

RPM

10

4xø4.2

2xø3.8LS

4

Inlet pressure

Page 5: Qualification Documentation (Q-doc)

Dimensions (mm), Air Driven Impact Throw Length, Air DrivenNozzles mm

Throwlength

41070144

1” ClampISO2852

11714

236

0 - 5

00 -

700

- 100

0 - 1

200

- 150

0

523

- 673

- 87

3 - 1

173

- 137

6 - 1

673

Ø69

31

Ø119 4” ClampISO2852

340

OPTIONRotacheckSensor

130

19.5

70

168

(5RPM) 4xø4.2

(5RPM) 2xø3.8

(16RPM) 4xø4.2(5RPM) 2xø2

(16RPM) 2xø3.8

(16RPM) 2xø2

m

8

7

6

5

4

3

2

1

2 3 4 5 6 7 8 9 10 11 12 bar13

4107

-000

5

Inlet pressure

Page 6: Qualification Documentation (Q-doc)

TRAX simulation toolTRAX is a unique software that simulates how the Toftejorg SaniJet 20 performs in a specific tank or vessel. The simulation gives information on wettingintensity, pattern mesh width and cleaning jet velocity. This information is used to determine the best location of the tank cleaning machine and thecorrect combination of flow, time and pressure to implement. A TRAX demo containing different cleaning simulations covering a variety of applicationscan be used as reference and documentation for tank cleaning applications. A TRAX simulation is free and available upon request.

Wetting Intensity

2.5

2.9

3.4

3.9

4.5

5.3

6.1

7.1

8.3

9.6

11

13

15

0.06

0.07

0.08

0.09

0.11

0.13

0.15

0.17

0.20

0.24

0.27

0.32

0.37

TD 523-208

(USgallon/ft2)

SaniJet 20 SaniJet 20

D2m H3m, Toftejorg SaniJet 20, 4 x ø4.2 mm, Time = 1.7min., Water consumption = 171 l

D2m H3m, Toftejorg SaniJet 20, 4 x ø4.2 mm, Time =7.6 min., Water consumption = 763 l

Page 7: Qualification Documentation (Q-doc)

Cleaning Pattern, the Golden SectionToftejorg SaniJet 20 operates according to the patented GoldenSection cleaning pattern (EP-Patent No.: 0495883, US-Patent No.:5,279,675), which is unique in building up a uniform pattern. Thepattern starts very coarse and refines itself in a step-less way by layingout the tracks approximately in the middle of the two most distanttracks already made. This means that the jets always clean the areascontaining the most remaining product, and thereby remove as muchdeposit as possible in the shortest possible time. In some instances,this method of cleaning can even render a complete cleaning patternunnecessary. The Golden Section is the most suitable cleaning patternfor an effective pre-rinse.

Golden Section Cleaning Pattern Traditional Cleaning Pattern

Page 8: Qualification Documentation (Q-doc)

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Alfa Laval reserves the right to change specifications without prior notification.

How to contact Alfa LavalContact details for all countriesare continually updated on our website.Please visit www.alfalaval.com toaccess the information direct.

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