Becomes the world’s first and the only capsule manufacturer to receive it
ACG -- a leading supplier of fully integrated solutions to the global pharmaceutical and nutraceutical industry, has received a certification of compliance from Clean Label ProjectTM for its ACGcapsTM H+. ACG Capsules has long been recognised for the quality and integrity of its ‘clean capsule’ design and manufacture and with this accreditation it has become the world’s first capsules to receive the certification from the Clean Label Project.
As cases of COVID-19 began to intensify across the U.S.A. in early spring, a diagnostics manufacturer reached out to ESS Technologies—a provider of complete packaging line design, manufacture, and integration—to build two identical filling systems with automated cap torque for diagnostics vials to be used in manufacturing COVID-19 test kits. The system needed to be fast and capable of filling up to 120 vials per minute. ESS introduces its FC Series Flexible Filler/Capper for vials and small bottles. Available in semiautomatic and fully automated configurations, the Flexible Filler/Capper is designed to use a circular puck conveyor system to transport vials or small bottles to the inline filling system. A timing screw drive is meant to position six vials beneath the six-up diving nozzle assembly where a precise amount of diagnostic reagent is dispensed. The cap placement is automated using Fanuc Scara robots and a cap feeder. A three-up final torque station is then supposed to apply the amount of torque to the caps. Model FC60 is designed to handle up to 60 vials per minute while Model FC120 is made to fill 120 vials per minute. The Flexible Filler/Capper for vials and small bottles uses Allen Bradley PLC controls and a 6” color touchscreen HMI for ease of operation. An optional 10” HMI is available. The system is designed to provide changeover under 10 minutes, and fast delivery. ESS, working closely with their suppliers, delivered the first two systems within weeks of the order and ahead of schedule. The two systems will allow the diagnostics manufacturer to significantly increase the production of COVID-19 testing vials, says the company.
Sterile and antiviral packaging: unlocking the potential of business continuity and resilience during COVID-19 pandemic
The COVID-19 pandemic has presented a humanitarian crisis, creating an extraordinary strain on society and affecting millions of people around the world. The speed and depth of disruption is creating unprecedented challenges for industries and is having a growing impact on the global economy. Beyond the negative impact of a traditional economic downturn due to factory closures, supply chain disruptions, movement restrictions and social distancing requirements, the pandemic has put the medical industry at the centre stage. In the current scenario, the healthcare industry is witnessing an unparalleled demand for diagnostic tests, personal protective equipment (PPE), medical ventilators and other critical medical supplies. With potentially high risk of infection, healthcare professionals (HCPs) are also facing significant challenges in providing specific and effective care (often remotely). Hospital systems are becoming overwhelmed with the rapidly increasing number of COVID-19 patients, which is weighing heavily on the pharmaceutical industry. While research efforts to find effective drugs against the novel coronavirus are picking up pace, it is imperative to tackle another big challenge – ensuring the safety and security of drugs and medical supplies until they reach the hands of those who need them the most. Many pharmaceutical companies remain focused on the immediate crisis – facilitating increased access to critical medicines and supporting HCPs, Intensive Care Units (ICUs), clinics, hospitals and patients in new ways. Overall, the COVID-19 pandemic has caused massive disruptions to the healthcare system. While pharma companies recognise and are responding to immediate needs, pharmaceutical packaging companies are experiencing a new set of challenges.
Closed Male Luer (Valve)
- Patented covered male luer technology
- Drip free disconnection
- Automatic shut-off upon disconnection
- Allows delivery through any female luer valve / port
- Anti-unwinding version to prevent unintentional removal
Closed Vial Access Device, 13 mm, 20mm and 28mm
- Patented closed vial access
- Traps vapors without compromising sterility
- Integrated swab able valve, luer connection
- “Clean Air” pressure equalization through 0.2mm one way filter
- One way valve traps vapors (even if removed from vial)
- Needle-free with non-coring, plastic spike
Infusion Access Device – Dry Spike
- Allows for use in standard IV bags, glass bottles, and other rigid containers
- Novel, safe infusion access
- Integrated swab able valve, luer connection
- Glass (rigid) bottle drug compatible
- One-way air inlet filter for “clean air” vent
- Dry access, internal pierce-able septum
Neutral Needle – Free Valve
- Neutral displacement upon disconnect
- Rated for pressures above 300 psi
- Low priming volume
- Easy to disinfect
- Non-tortuous path
Technical Features : Fewer steps than comparable pre-filled options Utilizes standard drug vial configurations Self contained and compact sterile system Vented for easy and complete drug withdrawal Intuitive Visual indication of proper mix1 Usage Push device down to actuate, mixing with drug Pull up plunger, aspirating mixed drug into syringe Disconnect syringe from device
- Three Mondi plants in Germany (Halle, Steinfeld and Gronau) are set to produce and donate 10,000 protective gowns to workers in local nursing homes and retirement facilities
- The initiative will involve using extruded PE tubes to be assembled into single-use protective garments
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 6 May 2020. Participation to the meeting of the Executive Steering Group was extended to all the heads of the national competent authorities (NCAs) of EU Member States to discuss additional actions by EU authorities to ensure the continued availability of medicines in Europe during the ongoing COVID-19 pandemic.
In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).
The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data in the context of the rolling review of remdesivir.
In addition, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from another study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy. Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir for an additional 5 days. The option to shorten treatment duration also means that more patients may be able to receive the medicine, which is in very high demand worldwide.
Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation.
More information is available in the PDF iconsummary on compassionate use and the PDF iconconditions of use of remdesivir.
More about the medicine
Remdesivir is an antiviral medicine which is being investigated for the treatment of COVID-19. Remdesivir is a ‘viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying). It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease.
Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.
More about the procedure
National competent authorities can ask EMA for an opinion on how to administer, distribute and use certain medicines for compassionate use under Article 83 of Regulation (EC) No 726/2004.
Compassionate use programmes enable patients to gain access to unauthorised medicines in emergency situations. This complements the possibility to enroll patients in ongoing clinical trials.
Contec, Inc., Milliken partner to produce Sporicidin® brand disinfectant qualified to kill coronavirus
-- Leading manufacturers work to fill high demand for antibacterial cleaning solutions
Our priorities have not changed, we focus on keeping our employees safe for their own health. At the same time it is the best guarantee to minimise any negative impact on business continuity.
I am therefore happy to confirm that until now the interruptions have been limited. This would certainly not have been the case if we would not have taken pro-active measures as soon as practical. Despite all the actions we have taken, our overall output has been somewhat affected where we have had to reduce staffing levels, mainly due to quarantine regulations imposed by the Turkish Ministry of Health for employees with higher health risks.
In combination with a significant increase in demand, this has resulted in longer lead times for some products of at least one week extra. We apologise for any inconvenience this is causing. We are working hard to overcome these issues, but it is realistic to assume that this situation will continue for several more weeks.
With respect to the weekend curfews which have been announced in Turkey for the remainder of April, we have received the confirmation from the Internal Affairs that as a supplier of both the healthcare and food industry we will be exempt. Our employees will therefore be allowed to travel to work also during the weekends and our operations will continue to produce as normal.
We will monitor the situation continuously and will keep you informed of future evolutions. Please do not hesitate to contact your local Korozo contact, if you have any further questions.
We appreciate your support and cooperation and we wish you all healthy and safe days.
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