Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I need some advise.  Currently we do not have a microbiology lab.  We have a clean room, manufacturer product, (think of an orthopedic screw), etc.  But all our micro work is done by a lab close to our facility.  This seemed to make sense, but we're now wondering as the costs seem high.  We are thinking of hiring a micorbiologist and setting up a lab.

Questions: 

1. What skills for the microbiologist, we were going to look for someone with a MS degree and experience with sterile manufacturing.  Suffice? insufficient? too high?  What is appropriate in skills?
2. What equipment will we need? 

Original Message------

This message was posted by a user wishing to remain anonymous

I need some advise.  Currently we do not have a microbiology lab.  We have a clean room, manufacturer product, (think of an orthopedic screw), etc.  But all our micro work is done by a lab close to our facility.  This seemed to make sense, but we're now wondering as the costs seem high.  We are thinking of hiring a micorbiologist and setting up a lab.

Questions: 

1. What skills for the microbiologist, we were going to look for someone with a MS degree and experience with sterile manufacturing.  Suffice? insufficient? too high?  What is appropriate in skills?
2. What equipment will we need?