RE: [PMFLIST] Direct Transfer Sterility Test

Answers to your questions:

1. Depends on what you mean by volume. We typically direct transfer less than 1 g of product per medium bottle. For reconstituted product we usually transfer 1 to 2 ml. Regarding the number of samples, we have tested up to 100 samples per medium (for a dose verification).

2. Single solid dose (or reconstituted sample) per 200 mL of medium.

3. 100 mg of sample to 200 mL of medium.

4. Clean room.

5. none

Bob

Robert F. Guardino
Associate Director Microbiology
AAI International
2320 Scientific Park Drive
Wilmington, NC 28405
Phone:  (910) 254-7635
Fax:    (910) 254-7416
e-mail: [log in to unmask]