The transfer of materials into confined manufacturing spaces is a very critical operation, especially in the case of an aseptic environment. Depending on the manufacturing step, the failure of containment might have detrimental consequences, from the disruption of the working schedule (repeat preparation activities) to the rejection of the ongoing batch and impact to the sterility assurance of the previous manufacture. This article will provide an overview of the technology systems that allow passage of materials through the sterile barrier without breaking it and some useful tips to design the rapid transfer port.
One of the main challenges organizations that are developing a QMS face, is undoubtedly the starting point. This blog defines a QMS with its advantages, lists examples of QMS used in organizations, and explains six helpful tips that companies should undertake before starting the development and implementation of a QMS.
Digitization, automation, and the latest R&D models can lead to a true transformation of labs. But what challenges do we need to overcome together so that researchers can provide us with the therapies of the future; faster and more efficiently?
Every aspect of the manufacturing process is examined and covered by Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP) to guard against any risks that can be catastrophic for products such as cross-contamination, adulteration, and mislabeling. But what are the GMP and GDocP guidelines exactly? GMP and GDocP are extensive concepts which are discussed further in this blog.
It’s June, or better known as Pride Month. A month when the world focusses on equality, acceptance, and respect. Next to pi life sciences’ abundance of technical knowledge (which we like to share with the world at large: workshops, webinars and, of course, our consultants) we also carry certain values. Have you ever wondered what makes us tick? Well, let us introduce you to what we call the pi DNA: the values we strive to achieve every single day so that each of us can become the embodiment of what pi symbolizes. You could say we even take pride in them. In four blogs we will pridefully shine a light on each of these values. Join us on this valuable (pun intended) journey to the heart of pi. Starting with integrity and respect.
To guarantee the quality of medicine, various measures are taken within the pharmaceutical industry. First, incoming goods are checked before they are used. During the subsequent production process, the following measures are taken: the production areas are set up following GMP standards, in-process controls are carried out during the production process, only validated equipment will be used, etc. After the entire production process, the batches are subjected to strict quality control.
It’s that time again. We are going to take another look at what makes up our pi DNA. Today we will be looking at our second value: professionalism. I can hear you thinking: easy, no? But is it really? Have you ever thought about what professionalism means to you? If you haven’t, take a moment and write down some keywords that bring, for you, “being a professional” alive. You’ve thought about it already? Well, then I invite you to do the same. Now let’s compare notes and let’s discover what professionalism truly is.
No one can whistle a symphony. It takes an orchestra to play it. And it only takes a single bad note to ruin it. Teambuilding and teamwork are concepts that we are all well aware of. There are project teams, HR teams, management teams, recruitment teams, … Teams aplenty! But how do you build a real team? How do you work as a team? Here at pi, we have our ways.
Welcome to the third blog about what makes up our pi DNA: team spirit!
It’s the final countdown! Well, at least for our blogs about our pi DNA. We’ve had lots of fun writing these and we have plenty of ideas to follow up on this series. So with the necessary grandeur, we are pleased to present you with our final core value: engagement and entrepreneurship
As the second wave of infections is significantly rising globally after strict regulations were relaxed during the end of spring and summer, Covid19 has been impacting our lives again daily and causing remarkable stress in each one of us.