Equipment qualification is a
necessary and critical step in
ensuring that a product or service
is provided accurately and
consistently with requirements
aligned with medical device
manufacturing and testing. This is
especially critical for the medical
device industry because the
medical device manufactured by a
company is considered a piece of equipment and requires qualification, as much as ...
Point Of Care Testing in Clinical Trials – Page 1
Point of care (POC) testing is diagnostic testing performed promptly and conveniently in the vicinity of the patient, avoiding the often lengthy procedure of sending samples to be processed in a central laboratory. This gives rise to the alternative names of near‐patient and bedside testing. The requirement for POC testing is increasing, with the ...
Pre-filled syringes are quickly becoming a viable alternative to vials. Review the benefits they offer, including reduced overfill requirements, decreased waste and enhanced product differentiation.
Prefilled syringes are a fast- growing alternative to vials in the parenteral product market due to the many advantages they offer relative to vials. These include reduced overfill requirements, ...
Considerations in the Use of DataTrace RH Data Loggers for Monitoring Ethylene Oxide Sterilization Processes
Data loggers that measure relative humidity (RH) and temperature are routinely used in Ethylene Oxide (EO) sterilization processes for validation and routine monitoring. An understanding of the effects of EO exposure on the sensing element of the RH data logger is critical to the ...
Close control of the EtO sterilization process is required to ensure the safety of medical devices. Requirements for validation and control of EtO sterilization have increased substantially in recent years. The ANSI/AAMI/ISO (American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization) 11135 standard "Medical ...
The use of advanced monitoring technologies in four key aspects of EtO sterilization can yield substantial business and regulatory benefits.
The use of ethylene oxide (EtO) gas has long been a dominant mode of terminal sterilization. Today, close to half of all medical devices produced in the United States are processed with EtO.
When it comes to the steam sterilization of liquid media, there are a number of user concerns that are handled in various ways. Monitoring these cycles with biological indicators (BIs) and the various restrictions and cycle modifications that are done can lead to a false positive or failed cycle. Here are only a few of the cycle modifications done or restrictions applied by users for the steam ...
The requirements for sterile technique depend on the experimental situation including the growth media used, the experimental organism, the duration of the experiment and the intended use of the culture. For these experiments the most serious contaminant is mold. Many common molds grow well on yeast media and compete effectively to over-grow the plates and obscuring the yeasts that do manage to ...
Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and costeffective.
Part 1 of Running a ...
Company descriptions and contact
information are quoted
from the company's website or other promotional information. JAZ'D is not responsible for
the accuracy
of this information. Unless specifically noted, JAZ'D is not sponsored by, affiliated with
or otherwise
connected with any of the listed companies.
