Archives for December 2018

Merry Christmas

Can an Isolator still be used without a Cleanroom

 

The answer is complicated.

Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions.  Usually, the certifier will conduct particle tests and airflow studies while a technician is compounding and transferring materials.

Cleanroom Training and Evaluation

As cleanroom experts, we also provide on-site clean room training.

This is the table of contents for our, joint commission evaluated, clean room training manual.

 

This on-site training can be implemented in several ways.

Exposure to Hazardous Materials during Shipping and Receiving

 

Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and exposure risk.

The first known, is actually outside of the clean room and is the pre-cleaning station.