Protocols

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ENDO

Endotoxin testing

3 stepsEdit
1

Sample prep

Endotoxin testing L1 · 1 person

1h

hands-on

2

Incubation

No capabilities

4h

hands-on

3

Review

Different person No capabilities

1h

hands-on

EM

Environmental monitoring

1 stepsEdit
1

Covers all

Incubator-1 L1 Environmental monitoring L1 · 3 people

4h

hands-on

BIO

Microbial bioburden

Aseptic preparation, incubation, enumeration, and review

3 stepsEdit
1

Aseptic sample preparation

No capabilities

2h

hands-on

2

Incubation

No capabilities

24h

unattended

3

Enumeration and review

No capabilities

2h

hands-on

MYCO

Mycoplasma testing

4 stepsEdit
1

Sample prep

Mycoplasma testing L1 · 1 person

1h

hands-on

2

Loading

Biofire L1

2h

hands-on

3

Readout

Mycoplasma testing L1 · 1 person

2h

hands-on

4

Review

Different person Mycoplasma testing L2 · 1 person

1h

hands-on

BACT

Sterility test run

4 stepsEdit
1

Sample prep

Sterility testing L1 · 2 people Isolator L1

7h

hands-on

2

Incubation

Incubator-1 L1

168h

unattended

3

Readout

Sterility testing L1 · 1 person

4h

hands-on

4

Review

Different person Sterility testing L2 · 1 person

2h

hands-on

DISS

Tablet dissolution

Six-vessel dissolution followed by HPLC quantitation

3 stepsEdit
1

Media and apparatus preparation

No capabilities

1h

hands-on

2

Dissolution run

No capabilities

2h

hands-on

3

HPLC quantitation

No capabilities

3h

hands-on