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Due to the COVID-19 pandemic, Sharp has implemented many additional health, safety and cleaning precautions throughout its facilities in order to ensure the safety of our employees, their families and the products we are packaging.  The following practices – in line with the CDC guidelines – are now in place at all Sharp facilities until further notice.  These precautions will not be documented into the packaging record unless stated below.

General COVID-related health and safety precautions at Sharp facilities

  • Any employee who does not feel well is cautioned not to report to work.
  • Any employee who has been absent will be monitored and cleared through HR prior to returning to work.
  • To minimize the number of people at each facility, employees are working remotely wherever possible and visitor restrictions are in place.
  • Mandatory temperature monitoring has been implemented prior to entering Sharp facility
  • Additional cleaning staff have been hired to continuously clean in cafeterias, hallways and locker rooms throughout the day to help ensure a safe working environment. 
  • Basic production shifts have been shortened by 30 mins to minimize the possibility of cross-shift exposures in locker rooms
  • Employee flow in and out of the facility has been re-routed to further minimize cross-shift exposure

Specific in-production health and safety practices

In addition to the normal GMP gowning procedures, the following rules are now in place for employees:

  • Employees must:
  • Wash hands for a minimum of 20 seconds before going to/returning to the packaging lines
  • Wear gloves at all times and avoid touching their face (re-glove as necessary)
  • Wear a surgical face mask or N95 face masks as appropriate, both have been made available to all employees working on the production floor.
  • Maintain a 6′ distance between each associate or a divider between associates
  • Sneeze or cough into a bent elbow at all times
  • All production surfaces to be cleaned with 70% IPA at the start of each shift. (Touchpoints surfaces are cleaned three times a day).
  • Surface cleans are documented in the packaging records and/or cleaning logbook as a ‘general clean’ or ‘room cleaning’.

Sharp cleaning procedure in the case of a COVID-19 positive result
If an employee is found to test positive for COVID-19, the following procedure applies:

  • Sharp will determine when the employee was last at the facility, which room they were assigned to and which other Sharp employees they may have been in close contact with either on their last day in the facility (if more than 72 hours has passed) or for a period of 72 hours prior to the development of COVID-19 related symptoms. 
  • Those ‘close contact’ employees will be monitored for a full 14-day period and will stay at home if they begin to feel unwell. 
  • All Sharp production rooms are wiped down 3 times per day; however, Sharp will also review what cleaning procedures have taken place in the production room where the COVID-positive employee worked, over the previous 72 hours of since their last shift.  Based on that information, Sharp may take additional cleaning action up to and including a full major clean. 
  • Please note our current cleaning agents are effective against the Covid-19 virus.

Employee return to work policy

As employees may or may not have been tested for COVID-19, the following guidelines, in line with CDC guidelines, will be adhered to for those returning to work: 

Employees must meet all of the following 3 conditions:

  • Display no fever for at least 72 hours (3 full days of no fever, without the use of medicine that reduces fevers)
  • All other symptoms must have improved (for example, cough or shortness of breath have improved)
  • At least 7 full days have passed since symptoms first appeared

Keeping clients informed about positive Covid-19 cases at Sharp 

Whether Sharp need to inform clients about positive cases of COVID-19 depends on the following scenarios:

Primary Room:  If an employee develops COVID-19-related symptoms while on campus and is involved in primary packaging activity, the employee will be removed and the room will be isolated and cleaned in line with procedure (as mentioned above).  An Event Level1 will be recorded in the batch documentation.  Therefore, the review teams at the client company will see the event and what subsequent actions were taken.

Secondary Room:  As there is no direct exposure to product in the secondary process, cleaning will take place as noted above but no events will be initiated for the packaging process.

Research tells us that this virus does not live outside the body nor on surfaces for any extended length of time (estimated beyond 72 hours).  Based on the current practices in place at Sharp, any potential exposure of product is minimal and low risk.  Most product is shipped out of our facility an average of 21 days post-production.  Therefore, there is no risk that patients or the HCP could contract Covid-19 because of any potential exposure from packaging activities at Sharp.

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