COVID-19 had major effects on supply chain for numerous goods including cleaning and disinfection supplies. Products that usually had a quick turnaround were now on allocation and had a several week or even month lead time. For the life science industry, keeping facilities critically clean is vitally important to the manufacturing process. This shift in product supply led to facilities quickly adopting different, but comparable, products into their cleaning procedures. This rapid turnaround was unique for an industry that normally doesn’t deviate from the products being used in their cleanroom. However, when supply became increasingly limited, facilities were able to adopt similar products to keep manufacturing lines open and running.
Impact on Change Controls
Vaccines have been a highly discussed topic since the announcement of the pandemic due to COVID-19. The virus spread quickly throughout the world and the push for an approved vaccine to market was very strong. Research professionals in many organizations around the world began working immediately to create an authorized vaccine. The intense push has also created a sense of uncertainty among many Americans as to whether they would even take a vaccine that came to market so quickly. According to a poll in September 2020, Americans are split with 51% of adults saying they most likely would get vaccinated if one were available versus 49% who say they would most likely not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May 2020. This fear has raised concerns among many professionals. However, the vaccine approval process has not changed.
Contec remains committed to our pharmaceutical manufacturing partners delivering the highest quality contamination control products to support this massive vaccine production effort.
a COVID-19 vaccine
Scroll for more
It’s safe to say, the year 2020 has been one many of us would like to forget. COVID-19 has dominated the headlines and has affected various things in the life science industry including product supply and visitor restrictions. Despite the setbacks of COVID-19, the cleanroom industry is moving forward to make cleanrooms cleaner and safer. Here are the top 5 cleanroom news topics for 2020.
of Residue Removal
It’s vitally important to disinfect surfaces in a cleanroom. However, the components that make up a disinfectant are the reason you see residue on surfaces after applying them. Many regulatory bodies address residues in their guidelines:
“Disinfectants applied on potential product contact surfaces are typically removed with 70% alcohol wipes. The removal of residual disinfectants should be monitored for effectiveness as a precaution against the possibility of product contamination.”
The advancement of Personalized Medicine has been remarkable. Personalized medicine is the tailoring of medical treatment to the individual characteristics of each patient. This approach takes a person’s molecular genetic profile and analyzes it to see what makes them susceptible to certain things. Once physicians know this, they can customize a treatment plan specific to that patient’s genetic molecular profile which can minimize harmful side effects with the result being a more positive outcome.
Best practice training is imperative in the life science industry. Before 2020, many of these training sessions happened in person. However, once COVID-19 spread and companies closed their doors to outside visitors, onsite training for many companies was another casualty of the pandemic. . Companies had to adapt the way they trained employees. According to a Gartner poll, 84% of organizations had to cancel in-person trainings due to the Coronavirus, and 83% of those polled said they moved the in-person training to a virtual training. Virtual meetings and webinars made it possible to get valuable information from industry leaders in an effective way. Some companies have taken it a step further, creating virtual platforms for product recommendations and video training when representatives couldn’t be there in person.
-Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
“We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”
According to the FDA, in gene therapy for example, scientists can do one of several things depending on the problem that is present. They can replace a gene that causes a medical problem with one that doesn’t, add genes to help the body to fight or treat disease, or turn off genes that are causing problems.
Essentially, gene therapy modifies cells outside of the body, blood, bone marrow, or another tissue. It can be taken from a patient, and specific types of cells can be separated in the lab. A vector containing the desired gene is introduced into these cells, often using a specific virus as the carrier. The cells are left to multiply in the laboratory and are then injected back into the patient where they continue to multiply and eventually produce the desired benefit.
Gene therapy is giving options for improved or extended life to patients with difficult, even incurable diseases. Contec is proud to manufacture products for many companies in this field to create the clean work environments required for this cutting-edge technology.
EU Annex 1 Draft
“Cleaning programs should effectively remove disinfectant residues.”
But how can residues be removed effectively? First, it’s important to evaluate the severity of the residue. This will determine what removal aid should be used. These options include detergent, WFI, IPA, hydrogen peroxide and a dry wipe. To prevent residues from becoming an issue, implement a removal aid as part of a cleaning and disinfection program. Lastly, determine the frequency of this removal aid as part of the program.
Visit Contec's Virtual Learning tool