Reducing variability when testing residual seal force can be difficult to control. Since elastomeric vial seals relax in the short term and age in the long term, it is important to make sure that all specimens in a sample are capped at approximately the same time to minimize variability during testing.
Sep 3, 2021 · A vial container closure system for pharmaceutical, biological, cell, and gene therapies must maintain container closure integrity to ensure that the drug products remain stable and free of contamination from microbial ingress.
Jun 2, 2021 · To reduce product costs, speed fulfillment and delight customers you must continuously improve the inventory management process. Augmenting existing Enterprise Resource Planning (ERP) – Best practices in inventory management, and specifically inventory visibility and order management technologies, can augment a company’s existing ERP solutions.
Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and is required by regulators to demonstrate the aseptic capability of such processes. A successful program of APS and aseptic manufacturing requires significant operator training, skills, and supervision; thorough maintenance; effective cleaning and disinfection; significant oversight of every
After aliquoting the suspension into cryogenic screw-cap vials, the cells are snap-frozen by immersing the tubes in either ethanol-dry ice or liquid nitrogen and then stored in freezers (‑20 to -80°C) or liquid nitrogen (-150°C). 5 Repeated thawing and refreezing of the bacterial stocks will reduce cell viability and should be avoided.
Using blunt fill needles may also reduce the risk of coring (and needle stick injuries).3. To prevent vacuum formation, inject air into the vial equal to the volume to be withdrawn. When reconstituting a powdered drug, withdraw a volume of air equal to the amount of the diluent to be added. This will prevent positive pressure from developing
Jul 1, 2019 · The Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay (ASTM F2338 - 09 (2013)) is versatile and can be used on flexible film and inner seals on rigid containers to assess the seal integrity of a water bottle to closure interface. • Bubble emission test. Internal pressure that seals can withstand is
Mar 1, 1998 · A common approach to reduce analytical variability is to increase the number of replicates performed to reduce the short-term component of the analytical variability. Given that the overall analytical variation is inversely related to the number of replicates (Eq.
Pre-Analytical Phase is a term that refers to the steps and factors that affect the quality and reliability of laboratory tests. It covers the collection, handling, storage, and preparation of biological samples before analysis. Learn more about the importance, challenges, and solutions of pre-analytical phase in biochemistry, genetics, and molecular biology from ScienceDirect Topics.
Aseptic technique, designed to provide a barrier between the microorganisms in the environment and the sterile cell culture, depends upon a set of procedures to reduce the probability of contamination from these sources. The elements of aseptic technique are a sterile work area, good personal hygiene, sterile reagents and media, and sterile
May 23, 2019 · The Clinical and Laboratory Standards Institute (CLSI) offers extensive guidance about how to design and carry out the studies necessary to evaluate reagent lot-to-lot consistency as it pertains to both patient and QC specimens. 2 “The studies are structured to determine whether there is an unacceptable amount of variation in the new lot number,” says Yundt-Pacheco.
Mar 2, 2014 · Trends and Best Practices in Visual Inspection. Using best practices for manual or automatic inspection can improve the inspection process. Visual inspection ranks as an essential operation in parenteral drug production to ensure the safety of the drug product in its container, such as a vial or syringe. The industry is seeing an increased
materials. The practices and policies that have been organized into formal documents testify to the importance of following proper steps that will result in the highest quality specimens for research purposes. The use of proper procedures to produce biological specimens of the appropriate quality, as well as the collection of relevant clinical,
Nov 8, 2021 · Recommended Best Practices for Lyophilization Validation 2021 Part II is a comprehensive guide for the pharmaceutical industry on how to perform and document the validation of lyophilization processes. It covers topics such as protein concentration measurement, stability testing, and regulatory requirements. This article is the second part of a two-part series published in the Journal of
Sep 2, 2022 · It is no secret that legacy main-shaft sealing devices designed 100-plus years ago remain the primary seal technology still used today. However, when end users are selecting the best sealing solution for their water and wastewater applications, they must grasp what advanced technologies are available that will best fit their facility’s