Pharmaceutical Manufacturing – Autoclave Steam Sterilization

Pharmaceutical Manufacturing – Autoclave Steam Sterilization:

The Challenge

A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise.… more


Kaye Advanced Validator System

PV Experience with the Kaye Advanced Validator System (Kaye AVS)

Performance Validation (PV) has had a validated Amphenol Kaye AVS system in our temperature mapping equipment inventory for about a year and has used it to complete several mapping projects by different Kaye users.… more


Autoclaves/SIP

Autoclaves/Sterilizers/Steam-in-place (SIP)

Performance Validation has extensive autoclave and steam-in-place experience from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Kaye Validators, thermocouples, self-contained biological indicators (Bis), and BI incubator.… more


Controlled Temperature Storage

Controlled Temperature Storage

Performance Validation has extensive experience with controlled temperature and humidity storage mapping projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers.… more


Cryogenic Storage/Controlled Rate Freezers

Cryogenic Storage/Controlled Rate Freezers

Performance Validation has extensive experience with cryogenic storage and controlled rate freezer qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of Kaye Validators and thermocouples.… more


Incubators/Stability Chambers

Incubators/Stability Chambers

Performance Validation has extensive experience with incubators and stability chambers from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers.… more


Cold Storage (Refrigerators/Freezers)

Cold Storage (Refrigerators/Freezers):

Performance Validation has extensive experience with refrigerators, freezers, and sub-freezers from execution of qualification/validation projects with multiple clients across Pharmaceutical, Animal Health, and Medical Device life science industries.  These projects included mapping studies using PV’s own inventory of wireless Vaisala temperature and humidity data loggers and low temperature loggers.… more