Skyline Biotechnology Process Index page

 

 

Description

Name or number

 

 

When coming into the lab you must make sure that your bench tops and all materials are clean.   This SOP describes how you will clean your bench tops as well as how you clean and sanitize your glassware.

 

SOP 200 general cleaning

 

SOP 401023 sanitizing

 

 

All pieces of equipment that you use will have a Use Log associated with it.   On these logs you must state what you did with that piece of equipment.   You should enter calibration as well as the lot numbers of activities that you do.   Remember to make sure that the number on the use log matches the number of the piece of equipment that you are using. (Scales and Pumps do not have specific Log Sheets).  The use log for the Autoclave and for the water drops is located on a clipboard  on the wall just east or on your left of the autoclave.

 

Autoclave use log 1200.04

Distilled Water 1200.01

Generic Pumps 1200.12

Generic Scales 1200.14

Centrifuge 1200.06

Ultra Low Freezer

 

 

Pieces of Equipment that you should know how to use.   These SOP typically tell you how to use the piece of equipment.   You will have to perform a Fit For Use inspection any time you use a piece of equipment.   Make sure that the outside of the equipment is clean and Make sure that everything is working properly.

Autoclave SOP 3001.00

Still for Distilled Water SOP 0300.10

Centrifuge 510.1

Auto Dispense 3100.00

Ultra Low Freezer

General Fermenters 1000.00

Spin Plates 440812

 

 

 

The Inoculation Chain.  The Master stock culture is used to inoculate a 5ml broth culture.   This is usually performed in a very secure area and is absolutely clean.   If a contamination will occur it will occur usually at this point.    The 5ml culture is cultured in a roller tube and then used to inoculate a 50ml culture, which in turn is used to inoculate a 500ml culture, which in turn is used to inoculate a 2l culture.   These forms will document this process.   Remember that the inoculation chain is named (by lot) on the day that the transfer occurs and that the lots are further subdivided by labeling 1, 2 and 3 in that order.

 5ml to 50ml 5839.01

50ml to 500ml

5839.02

500ml to 2l   5839.03

 

The Harvest.  Collecting the spend media using Centrifugation 5839.04

 

 

What happens when something goes wrong?  These documents are ways of describing and starting the processes of looking for errors, mistakes and other items.