Background
Due to the lack of supply of protective equipment in both the US and Europe, recycling of protective masks by the plasma sterilization process H2O2 had been approved and put
into practice.
A summary of the announcement made in the US is presented below:
FDA lifts restrictions on Ohio-based Battelle’s mask-sterilizing technology amid
coronavirus shortages
COLUMBUS, Ohio – After a day of pressure from Ohio Gov. Mike DeWine, the U.S. Food and
Drug Administration late Sunday rewrote rules to allow full application of a potentially game-
changing Battelle technology to sterilize protective masks worn by those treating coronavirus victims.
The agency ruled that upgrading its emergency use authorization from partial to full “is
appropriate to protect the public health or safety.”
DeWine said Sunday night that he and Lt Gov. Jon Husted “just had a very productive call”
with the Food and Drug Administration. “I anticipate a positive announcement soon. We must
do all we can to protect our front-line workers.”
Husted tweeted: “This Ohio-driven solution has the potential to save lives now and in the future
across the United States.”
‘Life may change for us all’:How we respond to the coronavirus crisis will be defining, historians
say. Then the FDA issued a new waiver to Battelle, a Columbus-based non-profit. It said, “Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per chamber load” in its new machine that decontaminates the safest masks against coronavirus and can allow 20 reuses of the devices, which are in perilously short supply.
The company has two machines – each capable of cleaning 80,000 masks a day – ready to
go for Ohio. It also is deploying machines to New York, Seattle and Washington, D.C. That
means the new order could allow for up to 400,000 clean masks a day in the short run.
The FDA’s original limitation of 10,000 mask sterilizations each day prompted an angry news
release from DeWine and telephone and Twitter exchanges between the governor and
President Donald Trump.
DeWine issued an angry news release in the morning calling the FDA “reckless” for
dramatically limiting the number of cleaned masks. It was a sharp rebuke from a Republican
governor who until now has refrained from criticizing the Trump administration’s handling of
the COVID-19 outbreak.
New York is at war with the coronavirus:Expect the same across the US, experts warn.
DeWine talked to Trump later in the morning and said the president was willing to help.
In Europe, the Dutch Ministry of Health has ordered a trial of sterilizing masks for recycling in
a number of technologies.
According to the test results, using the H2O2 plasma sterilizer does not have mask deformation and even after two sterilization cycles the mask quality is still reasonable, only after the third cycle the mask quality degrades significantly.
Proposal for the purchase of plasma sterilizers
In mobilizing the effort that surrounds us all, BioPharmax offers plasma sterilizers for sterilizing / recycling masks (as well as for masks / protective clothing treatment prior to disposing). The sterilizers are manufactured in China of high quality standards for which CE certification for products and TUV certificates have been granted (see attached appendices). The sterilizers are manufactured for inventory and can be ready at the manufacturer’s premises for delivery within 10 business days from the order date. Due to the urgency, air transport may be considered and the sterilizers are offered at very attractive prices.
Supply
1. The products are manufactured for inventory so the delivery time is extremely short.
2. Due the current situation, it is difficult to predict the availability of flights. The product will be ready for delivery at the manufacturer’s premises within 10 working days from order.
Delivery
1. To hasten supply air transport may be considered.
2. Due the current situation, it is difficult to anticipate the cost of transport. The shipping cost will be given when booking is confirmed.
Additional Comments
1. Prices are in US dollars.
2. Prices are FOB China, and do not include transport, customs, import duties, VAT and/or any other taxes and levies.
3. 12-month warranty from supply, serviced by Biopharmax Company. 4. Offer validity: April 30, 2020.
About Biopharmax:
Biopharmax is a global design and construction provider of manufacturing facilities and systems for Biotechnology, and Pharmaceutical manufacturers. For over 40 years Biopharmax has catered industry leaders around the world and has obtained unique capabilities in process engineering and technology transfer related projects. Biopharmax process design expertise combined with a Turnkey execution assures our clients of a high end production facility completed on time, within a budget and with full compliance to the required standard.
Contact Info
Sheetal Kunjir
Biopharmax India Pvt LTD
+91+78-8754-8008
sheetal.kunjir@biopharmax.com
Aziz Shaikh
Biopharmax India Pvt Ltd
+91-77-9668-7711
aziz.shaikh@biopharmax.com