7/28/2019 Water Histograms 18 Dec 2003

1/60

0

2000

4000

6000

8000

10000

12000

14000

16000

18000

20000

1.00 1.07 1.14 1.21 2.04 2.11 2.18 3.01 3.08 3.15 3.22 4.05 4

7/28/2019 Water Histograms 18 Dec 2003

2/60

0

1000

2000

3000

4000

5000

6000

7000

1.00 1.07 1.14 1.21 2.04 2.11 2.18 3.01 3.08 3.15 3.22 4.05

7/28/2019 Water Histograms 18 Dec 2003

3/60

W

0

1000

2000

3000

4000

5000

6000

7000

1 8 15 22 29 36 43 50 57 64 71 78 85

7/28/2019 Water Histograms 18 Dec 2003

4/60

Purified Water SystemsHistograms: Typical

Uses

7/28/2019 Water Histograms 18 Dec 2003

5/60

Histogram of Softe

Sizing Assumptions 1 2 3

RO/DI skid drawoff 445.63 445.63 445.63

HVAC: Humidification, non-cGMP areas 358 358 358

HVAC: Boiler makeup 1517 1517 1517

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour 2320.6 2320.6 2320.6

Time (Day. Hour) 1.00 1.01 1.02

Tank Volume @Start of Hour 15000 15000 15000

Make-Up Volume 2320.6 2320.6 2320.6

Minimum tank inventory: 15000.0 L

100%

User Selectable

Initial Tank Volume 15000 L

Make-Up Rate 7500 Lph

Tank Working Volume 15000 L

Total weekly makeup 504706.22

7/28/2019 Water Histograms 18 Dec 2003

6/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

2.00 2.01 2.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

7/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

3.00 3.01 3.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

8/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

4.00 4.01 4.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

9/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

5.00 5.01 5.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

10/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

6.00 6.01 6.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

11/60

Histogram of Softe

Sizing Assumptions

RO/DI skid drawoff

HVAC: Humidification, non-cGMP areas

HVAC: Boiler makeup

(NOTE: RO/DI skid drawoff feeds USP PW tank. USP PW tank feeds WFI still,

clean steam generator, and CIP skids. Demands are not simultaneous.)

Total Soft Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 15000.0

100%

User Selectable

Initial Tank Volume 15000

Make-Up Rate 7500

Tank Working Volume 15000

Total weekly makeup 504706.22

1 2 3

445.63 445.63 445.63

358 358 358

1517 1517 1517

2320.6 2320.6 2320.6

7.00 7.01 7.02

15000 15000 15000

2320.6 2320.6 2320.6

7/28/2019 Water Histograms 18 Dec 2003

12/60

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

SystemMak

eup,LPH

Time (Day. Hour)

Soft Water Tank Volume and Makeup

7/28/2019 Water Histograms 18 Dec 2003

13/60

Histogram

System Ma

Sizing Assumptions 1 2 3 4 5 6

WFI feed 0 0 0 0 0 1413

Clean steam generation 445.625 445.625 445.625 445.625 534.175 445.625 4

CIP skid, suite 1 (all except final rinse) 2149 1153

Total USP Purified Water Usage liter per hour 445.625 445.625 445.625 445.625 534.175 3011.63 1

Time (Day. Hour) 1.00 1.01 1.02 1.03 1.04 1.05 Tank Volume @Start of Hour 3000 3000 3000 3000 3000 3000 2

Make-Up Volume 445.625 445.625 445.625 445.625 534.175 3000 1

Minimum tank inventory: 1534.0 L

51%

Average

User Selectable Maximum

Initial Tank Volume 3000 L Maximum

Make-Up Rate 3000 Lph Total Us

Tank Working Volume 3000 L

7/28/2019 Water Histograms 18 Dec 2003

14/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0

445.625 445.625 445.625 445.625 445.625 445.625 52

445.625 445.625 445.625 445.625 445.625 445.625 52

2.00 2.01 2.02 2.03 2.04 2.05 2

3000 3000 3000 3000 3000 3000 3

445.625 445.625 445.625 445.625 445.625 445.625 52

7/28/2019 Water Histograms 18 Dec 2003

15/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0

445.625 445.625 445.625 445.625 445.625 736.575 52

445.625 445.625 445.625 445.625 445.625 736.575 52

3.00 3.01 3.02 3.03 3.04 3.05 3

3000 3000 3000 3000 3000 3000 3

445.625 445.625 445.625 445.625 445.625 736.575 52

7/28/2019 Water Histograms 18 Dec 2003

16/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0 4

445.625 445.625 445.625 445.625 445.625 445.625 44

445.625 445.625 445.625 445.625 445.625 445.625 84

4.00 4.01 4.02 4.03 4.04 4.05 4

3000 3000 3000 3000 3000 3000 3

445.625 445.625 445.625 445.625 445.625 445.625 84

7/28/2019 Water Histograms 18 Dec 2003

17/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0

445.625 445.625 445.625 445.625 445.625 445.625 44

445.625 445.625 445.625 445.625 445.625 445.625 44

5.00 5.01 5.02 5.03 5.04 5.05 5

3000 3000 3000 3000 3000 3000 3

445.625 445.625 445.625 445.625 445.625 445.625 44

7/28/2019 Water Histograms 18 Dec 2003

18/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0

445.625 445.625 445.625 445.625 445.625 445.625 445

445.625 445.625 445.625 445.625 445.625 445.625 445

6.00 6.01 6.02 6.03 6.04 6.05 6

3000 3000 3000 3000 3000 3000 30

445.625 445.625 445.625 445.625 445.625 445.625 445

7/28/2019 Water Histograms 18 Dec 2003

19/60

Histogram

System Mak

Sizing Assumptions

WFI feed

Clean steam generation

CIP skid, suite 1 (all except final rinse) 2149

Total USP Purified Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume

Minimum tank inventory: 1534.0

51%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 3000

Tank Working Volume 3000

1 2 3 4 5 6

0 0 0 0 0 0

445.625 445.625 445.625 445.625 445.625 445.625 445

445.625 445.625 445.625 445.625 445.625 445.625 445

7.00 7.01 7.02 7.03 7.04 7.05 7

3000 3000 3000 3000 3000 3000 30

445.625 445.625 445.625 445.625 445.625 445.625 445

7/28/2019 Water Histograms 18 Dec 2003

20/60

0

1500

3000

4500

6000

7500

1.

00

1.

03

1.

06

1.

09

1.

12

1.

15

1.

18

1.

21

2.

00

2.

03

2.

06

2.

09

2.

12

2.

15

2.

18

2.

21

3.

00

3.

03

3.

06

3.

09

3.

12

3.

15

3.

18

3.

21

4.

00

4.

03

4.

06

4.

09

4.

12

4.

15

4.

18

4.

21

5.

00

5.

03

5.

06

5.

09

5.

12

5.

15

5

1 8

SystemMakeup,LPH

Time (Day. Hour)

USP PW Tank Volume and Makeup

7/28/2019 Water Histograms 18 Dec 2003

21/60

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run

0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000Make-Up Rate 1650

Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

22/60

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

23/60

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run

0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650

Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

24/60

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run

0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650

Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

25/60

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

26/60

H

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run

0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650

Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

1

0

6.00

3000

0

7/28/2019 Water Histograms 18 Dec 2003

27/60

H

Sizing Assumptions

1500 L Mammalian Media Prep

1500 L Mammalian Buffer Prep

Suite 1 Washer

Fill/finish: Dirty Parts Washer

Fill / finish: Vial Washer

Fill / finish: Clean Parts Washer

Fill / finish: CIP

Fill / finish: Lyophilizer Wash-Out

1780.00 Use points

1413.00 (max. consumption)

1780.00 Mam Suite 1, Cell Culture 25 lpm max per drop

1166.00 Mam Suite 1, V+ Purification 25 lpm max per drop

0.00 Mam Suite 1, V- Purification 25 lpm max per drop

1413.00 Suite 1 Media Preparation 25 lpm max per drop

400.00 Suite 1 Buffer Preparation 25 lpm max per drop

#REF! Suite 1 Washer

#REF!

150.00 Utility area: COP 959 l per run

500.00 Fill / finish: Dirty Parts Washer 150 l per run

500.00 Fill / finish: Vial Washer 500 l per run

706.00 Fill / finish: Clean Parts Washer 500 l per run

200.00 Fill / finish: CIP (WFI Rinse Only) 706 l per run

Fill / finish: Lyophilizer Wash-Out 200 l per run

0.00

Total WFI Water Usage liter per hour

Time (Day. Hour)

Tank Volume @Start of Hour

Make-Up Volume 463.0 (time-averaged)

Minimum tank inventory: 1250.4

42%

User Selectable

Initial Tank Volume 3000

Make-Up Rate 1650

Tank Working Volume 3000

1500L Mammalian Purification Process Train #1 Starts on Monday

1

0

7.00

3000 3

0

7/28/2019 Water Histograms 18 Dec 2003

28/60

0

150

300

450

600

750

900

1050

1200

1350

1500

1650

1800

SystemMakeu

p,LPH

Time (Day. Hour)

Water for Injection System:System Make-Up and Tank Volume

Tank Volume WFI Makeup

7/28/2019 Water Histograms 18 Dec 2003

29/60

Sizing Assumptions 1 2

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter

M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter

Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC 0 0

AHU (humidification) 352.27 352.27

Line Loss 10% 35.227 35.227

Total Pure Steam Usage kg/hr 387.5 387.5

USP Water Supply, LPH 782.285775 445.63 445.63

Time (Day. Hour) 1.00 1.01

Time-averaged production 407.5

Maximum Pure Steam Load 680 kg/hr

Line loss, maximum 68.0

Blowdown 102.0

Safety factor 20%

Pure steam generator 1100 kg/hr

Pure Steam Pressure 2.4 bar

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

7/28/2019 Water Histograms 18 Dec 2003

30/60

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter

Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0

Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2

0 0

352.27 352.27 3

35.227 35.227 3

387.5 387.5 3

445.63 445.63 4

2.00 2.01

7/28/2019 Water Histograms 18 Dec 2003

31/60

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter

Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0

Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2

0 0

352.27 352.27 35

35.227 35.227 35

387.5 387.5 38

445.63 445.63 44

3.00 3.01 3

7/28/2019 Water Histograms 18 Dec 2003

32/60

H

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter

M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0

Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2 3

0 0 0

352.27 352.27 352.27

35.227 35.227 35.227

387.5 387.5 387.5

445.63 445.63 445.6

4.00 4.01 4.02

7/28/2019 Water Histograms 18 Dec 2003

33/60

Hi

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter

M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter

Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2 3

0 0 0

352.27 352.27 352.27

35.227 35.227 35.227

387.5 387.5 387.5

445.63 445.63 445.63

5.00 5.01 5.02

7/28/2019 Water Histograms 18 Dec 2003

34/60

H

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter

M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter

FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0

Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2 3

0 0 0

352.27 352.27 352.27

35.227 35.227 35.227

387.5 387.5 387.5

445.63 445.63 445.63

6.00 6.01 6.02

7/28/2019 Water Histograms 18 Dec 2003

35/60

His

Sizing Assumptions

Suite 1 Media Prep

Suite 1 Buffer Prep

500 L Mammalian Cell Culture Process Suite 2 Starts on Monday

Use points

Rooms (max. consumption)

Building 1C

M1-CC-1 Mam Suite 1, Cell Culture SIP: 0.0803 kg/liter

M1-P1 Mam Suite 1, V+ Purification SIP: 0.0803 kg/liter

M1-P2 Mam Suite 1, V- Purification SIP: 0.0803 kg/liter

Mam Suite 1 Buffer Preparation SIP: 0.0803 kg/liter FF-Auto Filling Suite Autoclave 230 kg/load

End user load excluding HVAC

AHU (humidification)

Line Loss 10%

Total Pure Steam Usage kg/hr

USP Water Supply, LPH 782.285775

Time (Day. Hour)

Time-averaged production 407.5

Maximum Pure Steam Load 680

Line loss, maximum 68.0Blowdown 102.0

Safety factor 20%

Pure steam generator 1100

Pure Steam Pressure 2.4

Blowdown percentage 15%

Minimum load 35%

1500L Mammalian Purification Process Suite 1 Starts on Monday

1 2 3

0 0 0

352.27 352.27 352.27

35.227 35.227 35.227

387.5 387.5 387.5

445.63 445.63 445.63

7.00 7.01 7.02

7/28/2019 Water Histograms 18 Dec 2003

36/60

Histogram of

Sizing Assumptions 1 2 3 4 5

Suite 1 biowaste 2957 70

Total biowaste liter per hour 0 0 0 0 70

Time (Day. Hour) 1.00 1.01 1.02 1.03 1.04

Tank Volume @ End of Hour 0 0 0 0 0

Throughput rate 1800 1800 1800 1800 1800

Tank Working Volume 2500 2500 2500 2500 2500

% of working volume 46% 0.00% 0.00% 0.00% 0.00% 0.00%

User Selectable

Initial Tank Volume 2500 L

Make-Up Rate 1800 Lph

Tank Working Volume 2500 L

Max inflow 2957 Lph

49.28 liter/min

4

7/28/2019 Water Histograms 18 Dec 2003

37/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

2.00 2.01 2.02 2.03 2.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

38/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

3.00 3.01 3.02 3.03 3.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

39/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

4.00 4.01 4.02 4.03 4.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

40/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

5.00 5.01 5.02 5.03 5.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

41/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

6.00 6.01 6.02 6.03 6.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

42/60

Histogram of C

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 46%

User Selectable

Initial Tank Volume 2500

Make-Up Rate 1800

Tank Working Volume 2500

Max inflow 2957

49.28

1 2 3 4 5

0 0 0 0 0

7.00 7.01 7.02 7.03 7.04

0 0 0 0 0

1800 1800 1800 1800 1800

2500 2500 2500 2500 2500

0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

43/60

0

200

400

600

800

1000

1200

1400

1600

1800

2000

Biowaste,liters

Time (Day. Hour)

Cell Culture Biowaste Surge and Throughput Th

7/28/2019 Water Histograms 18 Dec 2003

44/60

Histo

Sizing Assumptions 1 2 3 4 5 6

Suite 1 biowaste 2957 0 0 0 0 70 1153

Total biowaste liter per hour 0 0 0 0 70 1153

Time (Day. Hour) 1.00 1.01 1.02 1.03 1.04 1.05

Tank Volume @ End of Hour 0 0 0 0 0 0Throughput rate 1800 1800 1800 1800 1800 1800

Tank Working Volume 2000 2000 2000 2000 2000 2000

% of working volume 58% maximum 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Ave

User Selectable Max

Initial Tank Inventory 0 L

Make-Up Rate 1800 Lph 30 Liters/min

Tank Working Volume 2000 L

Maximum Inflow 2957 Lph 49.2833 Liters/min

Time-averaged inflow 49.1 Lph 0.81776 Liters/min

7/28/2019 Water Histograms 18 Dec 2003

45/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

2.00 2.01 2.02 2.03 2.04 2.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

46/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

3.00 3.01 3.02 3.03 3.04 3.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

47/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

4.00 4.01 4.02 4.03 4.04 4.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

48/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

5.00 5.01 5.02 5.03 5.04 5.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

49/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

6.00 6.01 6.02 6.03 6.04 6.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

50/60

Histo

Sizing Assumptions

Suite 1 biowaste 2957

Total biowaste liter per hour

Time (Day. Hour)

Tank Volume @ End of HourThroughput rate

Tank Working Volume

% of working volume 58% maximum

User Selectable

Initial Tank Inventory 0

Make-Up Rate 1800

Tank Working Volume 2000

Maximum Inflow 2957

Time-averaged inflow 49.1

1 2 3 4 5 6

0 0 0 0 0 0

0 0 0 0 0 0

7.00 7.01 7.02 7.03 7.04 7.05

0 0 0 0 0 01800 1800 1800 1800 1800 1800

2000 2000 2000 2000 2000 2000

0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

51/60

0

250

500

750

1000

1250

1500

1750

2000

2250

2500

Inventory

,liters

Time (Day. Hour)

Biowaste (Kill System) Volume and Throughput Th

7/28/2019 Water Histograms 18 Dec 2003

52/60

Histogram of Process Waste

Sizing Assumptions 1 2 3 4 5 6 7

Suite 1 biowaste 2957 0 0 0 0 70 1413 1413

Fill/finish 1459

Clean steam condensate 266.135 0 0 0 0 70 0 0

Total process waste liter per hour 0 0 0 0 140 1413 1413

Time (Day. Hour) 1.00 1.01 1.02 1.03 1.04 1.05 1.06

Tank Volume @ End of Hour 0 0 0 0 0 0 0

Throughput rate 1800 1800 1800 1800 1800 1800 1800

Tank Working Volume 2250 2250 2250 2250 2250 2250 2250

% of working volume 51% maximum 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

Average Dai

User Selectable Maximum Da

Initial Tank Inventory 0 L

Throughput Rate 1800 Lph 30 Liters/min

Tank Working Volume 2250 L

Maximum Inflow 2957 Lph 49.283 Liters/min

Time-averaged inflow 210.7 Lph 3.5121 Liters/min

7/28/2019 Water Histograms 18 Dec 2003

53/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 0 64.24

0 0 0 0 0 0 64.24

2.00 2.01 2.02 2.03 2.04 2.05 2.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

54/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 230 64.24

0 0 0 0 0 230 64.24

3.00 3.01 3.02 3.03 3.04 3.05 3.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

55/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

4.00 4.01 4.02 4.03 4.04 4.05 4.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

56/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

5.00 5.01 5.02 5.03 5.04 5.05 5.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

57/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

6.00 6.01 6.02 6.03 6.04 6.05 6.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

58/60

Histogram of Process Waste

Sizing Assumptions

Suite 1 biowaste 2957

Fill/finish 1459

Clean steam condensate 266.135

Total process waste liter per hour

Time (Day. Hour)

Tank Volume @ End of Hour

Throughput rate

Tank Working Volume

% of working volume 51% maximum

User Selectable

Initial Tank Inventory 0

Throughput Rate 1800

Tank Working Volume 2250

Maximum Inflow 2957

Time-averaged inflow 210.7

1 2 3 4 5 6 7

0 0 0 0 0 0 0

0 0 0 0 0 0 0

0 0 0 0 0 0 0

7.00 7.01 7.02 7.03 7.04 7.05 7.06

0 0 0 0 0 0 0

1800 1800 1800 1800 1800 1800 1800

2250 2250 2250 2250 2250 2250 2250

0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00%

7/28/2019 Water Histograms 18 Dec 2003

59/60

0

250

500

750

1000

1250

1500

1750

2000

2250

2500

Inventory,

liters

Time (Day. Hour)

Process Waste Volume and Throughput Th

7/28/2019 Water Histograms 18 Dec 2003

60/60

WPU Correl'n WFI Correl'n Gal/min

25 647 294 294 353 353 8 29.41

30 688 313 313 375 375 8 31.27

60 867 394 394 473 473 10 39.40

70 912 415 415 497 497 11 41.4875 934 425 424 509 509 11 42.44

100 1028 467 467 561 560 12 46.71

150 1176 535 535 641 641 14 53.49

200 1294 588 589 706 706 16 58.86

250 1394 634 634 760 761 17 63.40

300 1482 674 674 808 808 18 67.37

350 1560 709 709 851 851 19 70.92

400 1632 742 742 890 890 20 74.15

450 1697 771 771 926 925 20 77.11

500 1758 799 799 959 958 21 79.88

600 1868 849 849 1019 1019 22 84.88

700 1966 894 894 1072 1072 24 89.36

750 2012 915 915 1097 1097 24 91.44

800 2056 935 935 1121 1121 25 93.43

1600 2590 1177 1177 1413 1413 31 117.7

USP PW Rinse WFI Final Rinse

Tank volume/water volum Tank volume/water volume

correlation correlation

Power Fit: y=ax^b Power Fit: y=ax^b

Coefficient Data: Coefficient Data:

a = 100.6452 a = 120.6076

b = 0.333367 b = 0.333541

2:1 fermentors/bioreactors

USP PW WFI Final Rinse, L

Total CIP

Vessel

Volume, L

CIP Fluid,

L

(for waste

NOTE: CIP volumes are based on an assumption of a flowrate of 3.46 liters/minute per metcycle time of 22 minutes is assumed, broken down as follows:

Initial rinse 2 minutes USP PWCaustic wash 2 minutes USP PWSecond rinse 4 minutes USP PW

Acid wash 2 minutes USP PWFinal rinse 12 minutes WFI