Estimated Lyophilzer Spec Sheet
280m^2 lyophilzer shelf area 355.6cm x 5328.62cm=189.49 m^2 per shelf
8 shelves total= 1515.92 m^2 per lyophilizer of usable space
1515.92/ 0.00017875 m^2 per vial
= 8,480,671 vials per process.
Total vials required= 34,831,428
34,831428/8480671=4.1 cycles
4.1cycles by 5 days
=20.5 days for lyophilization with one unit
This time line is still slightly too long and as such the use of three lyophilizers will be employed to reduce the process time to 6.5 days of processing requirements meaning we lack the need for interrupted CIP and SIP processes between lyophilzation runs.
Standard floor size for each of the lyophilisers is 360.6cm x5335.6cm
Three lyophilsers of this size side by side will therefore take up …show more content…
This section applies pressure to the semi closed caps of the vials sealing them in place after which its applies an alluminium cripping cover for the cap to protect it from wear and tear and becoming dirty.
IMA Pharma Multifill F800
For this process we have selected the IMA Pharma MultiFill F800 Series which is capable of capping and crimping 450 vials per minute. The dimensions of this unit are 5759mm x 1935 mm
11,143,665 mm^2 per unit.
11.1 M^2 per unit each unit can process 648,000 vials per day
Six units can cap 3,888,000 vials per day
This means the full quantity of vials can be capped within a total 9 days
6 units will require 66.6M^2 space
Inspection
Vial inspection is carried out by hand with several trained employees surveying each vial for imperfections. From each batch several vials will be selected for my thorough inspection by the inspection team. These vials are then analyzed used and automated detection system which scans the vial for a range of faults including improper stopper, vial damage, unusual colouration of product etc. Should these vials pass inspection they are passed onto the labeling process, should they fail however the batch may be scrapped entirely and the process will need to be re-evaluated and attempted …show more content…
There will be an airlock in from the main Alexion facility with changing and gowning facilities within. There will an adjoining transport in airlock for any and all facility equipment that may be needed. This adjoining airlock will be connect to the main storage facility allowing free transport of vials into the facility after correct decontamination procedures have been completed.
Due to the sensitive nature of the fill finish suite the entire facility will be kept in grade A air conditions throughout with full body gowning being a necessity for all workers. There will be a walkway leading up the length of the facility rough 1m wide for workers with spaces of 1.5m between machines carrying out separate duties. This allows workers ample room to manoeuvre while allowing for facility equipment movement as well. Finally after the final labeling and packing requirements have been completed the now packed vials will be placed back into the main storage room for pick up and
280m^2 lyophilzer shelf area 355.6cm x 5328.62cm=189.49 m^2 per shelf
8 shelves total= 1515.92 m^2 per lyophilizer of usable space
1515.92/ 0.00017875 m^2 per vial
= 8,480,671 vials per process.
Total vials required= 34,831,428
34,831428/8480671=4.1 cycles
4.1cycles by 5 days
=20.5 days for lyophilization with one unit
This time line is still slightly too long and as such the use of three lyophilizers will be employed to reduce the process time to 6.5 days of processing requirements meaning we lack the need for interrupted CIP and SIP processes between lyophilzation runs.
Standard floor size for each of the lyophilisers is 360.6cm x5335.6cm
Three lyophilsers of this size side by side will therefore take up …show more content…
This section applies pressure to the semi closed caps of the vials sealing them in place after which its applies an alluminium cripping cover for the cap to protect it from wear and tear and becoming dirty.
IMA Pharma Multifill F800
For this process we have selected the IMA Pharma MultiFill F800 Series which is capable of capping and crimping 450 vials per minute. The dimensions of this unit are 5759mm x 1935 mm
11,143,665 mm^2 per unit.
11.1 M^2 per unit each unit can process 648,000 vials per day
Six units can cap 3,888,000 vials per day
This means the full quantity of vials can be capped within a total 9 days
6 units will require 66.6M^2 space
Inspection
Vial inspection is carried out by hand with several trained employees surveying each vial for imperfections. From each batch several vials will be selected for my thorough inspection by the inspection team. These vials are then analyzed used and automated detection system which scans the vial for a range of faults including improper stopper, vial damage, unusual colouration of product etc. Should these vials pass inspection they are passed onto the labeling process, should they fail however the batch may be scrapped entirely and the process will need to be re-evaluated and attempted …show more content…
There will be an airlock in from the main Alexion facility with changing and gowning facilities within. There will an adjoining transport in airlock for any and all facility equipment that may be needed. This adjoining airlock will be connect to the main storage facility allowing free transport of vials into the facility after correct decontamination procedures have been completed.
Due to the sensitive nature of the fill finish suite the entire facility will be kept in grade A air conditions throughout with full body gowning being a necessity for all workers. There will be a walkway leading up the length of the facility rough 1m wide for workers with spaces of 1.5m between machines carrying out separate duties. This allows workers ample room to manoeuvre while allowing for facility equipment movement as well. Finally after the final labeling and packing requirements have been completed the now packed vials will be placed back into the main storage room for pick up and