FIELD OF TECHNOLOGY A transfer port apparatus and method enables the uncontaminated transfer of a sterile liquid from a relatively dirty environment to a relatively clean environment through a transfer port in an isolation wall that separates the dirty environment from the clean environment.
SUMMARY A bulk quantity of sterile liquid product must be transferred to smaller containers for distribution to end users. The transfer process begins by filling a product tank with product. The sterile liquid product is then conveyed from inside the product tank, through the inside of a product hose, and through the inside of a product tube. The product tube is a part of a transfer port apparatus. The sterile liquid is conveyed from the product tube into a filling hose and then into filling equipment, which sequentially fills a number of smaller containers.
Prior to being filled with the sterile liquid product, the interiors of the product tank, product hose, and product tube may be contaminated by biological agents and nonviable particles, such as dust. Both the biological agents and the nonviable particles will compromise the sterility of the sterile liquid product unless they are removed prior to filling the product tank and associated conduits. The sterile liquid transfer port rids the contamination by steam cleaning the product tank and associated conduits by use of a beta assembly and a sterilization docking cover.
Furthermore, the relatively dirty environment can contaminate the cleaner environment with nonviable particles. To avoid contamination of the cleaner environment, in which filling of the smaller containers takes place, a physical barrier between the dirty environment, in which the product tank is located, and the clean environment is interposed. The barrier is comprised of the alpha assembly of the sterile liquid transfer port in conjunction with the beta assembly.
Accordingly, the sterile liquid transfer port (“SLTP”) provides for safe, fast, economical, and cost effective (i) sterilization of the product container and conduits through which the sterile liquid product is transferred and (ii) isolation of the less clean environment from the clean environment.
Transfer of liquid product from a sterilized interior of the product tank 202 (located in the product suite 205) to the filling equipment 209 (located in the filling suite 204) is a fairly simple task once sterilization is complete. Transfer of the sterile liquid product is through a transfer port 201b in an isolation wall 201.
The alpha assembly of the SLTP also isolates the product suite 205, the less clean environment, from the filling suite 204, the clean environment. The product suite 205 houses a product tank 202 for containment of a bulk quantity of a sterile liquid product. The filling suite 204 houses filling equipment 209 for commercial packaging of smaller amounts of product. Typically, the product suite 205 has a lower level of cleanliness (for example, a Class 10,000 environment) than the filling suite 204 (for example, a Class 100 environment).
An example of the use of the SLTP is a pharmaceutical setting. The pharmaceutical setting gives rise to a requirement for moving a biological agent from the product suite 205 to the filling suite 204, where relatively small quantities of product are transferred into containers for distribution, such as aseptic vials and syringes.
The SLTP is comprised of an alpha assembly, a beta assembly, and a sterilization docking cover. The transfer port apparatus can also be comprised of (a) an isolation wall; (b) a product suite on a first side of the isolation wall; (c) a filling suite on a second side of the isolation wall; (d) an alpha assembly spanning a port in the isolation wall between the first and second sides of the isolation wall; (e) a product tank; (f) a means for sterilization of the product tank, a conduit, and a beta assembly; (g) the beta assembly configured for connection with the alpha assembly for sterile transfer of a product; (h) a conduit for transferring product from the product suite to the filling suite; and (i) equipment in the filling suite for filling product.
The transfer port apparatus implements a method of transferring a sterile liquid from a product suite to a filling suite by (a) sterilization of the means for transferring the sterile liquid to a product tube on a beta assembly; (b) insertion of an alpha assembly through a port in an isolation wall; (c) mating a beta assembly with the alpha assembly; (d) opening an alpha door into the filling suite; (f) connecting a means for transferring the sterile liquid from the product suite to the filling suite; and (g) transferring the sterile liquid from the product suite to the filling suite.
DESCRIPTION OF DRAWINGS The following drawings present embodiments of the SLTP.
FIG. 1 is an isometric view of the alpha and beta assemblies of the sterile liquid transfer port.
FIG. 2A is an exploded view of the alpha assembly.
FIG. 2B is an elevation view of the alpha assembly.
FIG. 2C is a cross-sectional view of the alpha assembly of FIG. 2B.
FIG. 2D is an elevational view of the alpha assembly viewed from the rear.
FIG. 2E is an isometric view of the alpha assembly with the alpha door closed.
FIG. 2F is an isometric view of the alpha assembly with the alpha door open.
FIG. 3A is an isometric view of the beta assembly from the front.
FIG. 3B is an exploded, isometric view of the beta assembly from the front.
FIG. 3C is a elevational view of the beta assembly from the rear.
FIG. 3D is a cross-sectional view of the beta assembly of FIG. 3A.
FIG. 4A is an isometric view of the product tank with the docking cover located on the product tank.
FIG. 4B is an isometric view of the beta assembly aligned for docking with the docking cover.
FIG. 4C is an isometric view of the beta assembly with the beta flange bayonets in the docking cover bayonet receivers.
FIG. 4D is an isometric view of the beta assembly fully docked with the beta flange bayonets in the docking cover bayonet receiver channels.
FIG. 4E is an isometric view of the docked beta assembly with a product hose and a steam drain hose attached.
FIG. 4F is an isometric view of the product tank in the steam sterilization mode.
FIG. 4G is a cross-sectional view of the beta assembly of FIG. 4F in the steam sterilization mode.
FIG. 5A is an isometric view of the beta assembly aligned for docking with the alpha assembly.
FIG. 5B is an isometric view of the beta assembly from the rear with the beta flange bayonets in the alpha bayonet receivers.
FIG. 5C is an isometric view of the fully docked beta assembly from the rear with the beta flange bayonets in the alpha bayonet receiver channels.
FIG. 5D is an isometric view of the alpha and beta assemblies from the front with the alpha door latched.
FIG. 5E is an isometric view of the alpha and beta assemblies from the front with the alpha door unlatched.
FIG. 5F is an isometric view of the alpha and beta assemblies from the front with the alpha door open.
FIG. 5G is an isometric view of the alpha and beta assemblies of FIG. 5F with a product hose and a filling hose attached.
FIG. 5H is an isometric view of the alpha and beta assemblies of FIG. 5F with dual product hoses and filling hoses attached.
FIG. 5I is an elevation view of the sterile liquid transfer port in the filling mode.
FIG. 5J is a detailed elevation view of FIG. 5H showing the sterile liquid transfer port in the filling mode.
DESCRIPTION OF EMBODIMENTS Overview. The SLTP isolates the clean environment and provides uncontaminated transfer of the sterile liquid product. Isolation of the clean environment is accomplished by a single step sterilization process. Uncontaminated transfer of the sterile liquid product is accomplished by the combination of the alpha assembly and the beta assembly.
These key functions, including sterilization of the beta assembly 100, isolation of the alpha assembly 10, and docking of the beta assembly 100 to the alpha assembly 10, effectively isolate the dirty product suite 205 from the clean filling suite 204 and enable the uncontaminated transfer of sterile liquid between the two suites 205 and 204. The process of uncontaminated transfer of sterile liquid is relatively easy to accomplish as it requires no special tools or technical skills. It is fast as it does not require multiple cleaning and sterilization steps. It is also a cost effective solution for maintaining the required level of cleanliness of the product suite 205.
Detailed Description. The SLTP includes two main components—the alpha assembly 10 and the beta assembly 100.
FIG. 1 is an isometric view of the alpha and beta assemblies 10 and 100 of the sterile liquid transfer port. As shown in FIGS. 1 and 2, the alpha assembly 10 spans a transfer port 201b in an isolation window 201a. While the alpha assembly 10 is primarily associated with the filling suite 204 (a Class 100 environment), it also extends into the product suite 205 and its rear portion is exposed to the Class 10,000 environment. The alpha assembly 10 is configured to dock with the beta assembly 100. When the alpha and beta assemblies are docked, product can be rapidly transferred from the product suite 205 to the filling suite 204 without breaking containment. In the filling mode, the beta assembly 100 is mounted in-line with the alpha assembly 10. The beta assembly 100 is exclusively associated with the product suite 205. When the alpha and beta assemblies 10 and 100 are docked together and the alpha door 16 is open, a rigid product tube 109 extends into the filling suite 204 and is ready for attachment to a sterile flexible filling hose 208. The sterile flexible filling hose 208 delivers product (for example serum and vaccines) to commercially sized containers for wide distribution.
FIG. 2A is an exploded view of the alpha assembly 10. A flange gasket 18 is a seal between the alpha flange 11 and the isolation window 201a. The seal prevents leakage from the product suite 205 into the filling suite 204. A second flange gasket 18 is located in the product suite 205. The flange gasket 18 also serves the purpose of preventing leakage from the product suite 205 into the filling suite 204. Flange nut 17, located in the product suite, secures the alpha assembly 10 and the two flange gaskets 18 to the isolation window 201a.
FIG. 2B is an elevation view of the alpha assembly 10. The alpha assembly comprises an alpha flange 11 and an alpha door 16. The alpha door 16 only opens into the filling suite 204. The alpha door 16 is closed, unless a filling operation is in progress. It also remains closed when sterilization of the product tank 202, its associated hoses, and sanitary fitting adaptors is in process. The sterilization mode takes place prior to initiation of a filling operation.
FIG. 2B also illustrates a latch 13 affixed to alpha door 16. The latch handle 14 engages with latch 13. When latch handle 14 is in the up position, latch 13 is locked as is the alpha door 16. The alpha door 16 is in a locked position whenever it is closed to avoid inadvertent contamination of the filling suite 204. The mechanical latch interlock 15 prevents improper operation of the SLTP. For example, improper operation includes opening the alpha door 16 before the beta assembly 100 is docked with the alpha assembly 10; removing the beta assembly 100 from the alpha assembly 10 when the alpha door 16 is open; and rotating the latch handle 14 of the alpha door 16 when the alpha door 16 is open. Latch interlock 15 prevents accidental opening of alpha door 16. The alpha door 16 can be opened when the beta assembly 100 is docked with the alpha assembly 10 due to automatic disengagement of the latch interlock 15 by the beta assembly 100. The alpha door 16 can then be safely opened by rotation of the latch handle 14, counter-clockwise 180°.
FIG. 2B also illustrates a hinge assembly 12 comprised of hinge 12a, hinge pivot block 12b, and hinge pin 12c. Hinge 12a is affixed to alpha door 16. Hinge 12a rotates alpha door 16 around hinge pin 12c to both open and close alpha door 16. Hinge pivot block 12b acts as a support guide to maintain alpha door 16 in horizontal alignment during rotation and during the time it is in the open position.
FIG. 2C is a cross-sectional view of the alpha assembly 10 of FIG. 2B. The alpha assembly 10 is intended to maintain isolation of the product suite 205 from the filling suite 204 regardless of whether the SLTP is in the sterilization mode or the filling mode. The alpha assembly 10 is comprised of a flange 11, alpha door 16, bayonet receiver 11a, bayonet receiver channel 11b, flange nut 17, alpha seal 19, gasket 18 on the product suite side, and gasket 18 on the filling suite side. The alpha flange 11 is inserted into a transfer port 201b in an isolation wall 201. Prior to insertion of flange 11, gasket 18 on the filling suite side is put in place around the flange 11. Typically, an isolation window 201a is installed in an opening in the isolation wall 201 and the alpha flange 11a is installed in the transfer port 201b in the isolation wall 201. The isolation window 201a is used to monitor activity in the product and/or filling suites 204 and 205. After the alpha flange 11 is installed into a transfer port 201b, gasket 18 on the product suite 204 side is placed around the flange 11 and flange nut 17 is tightened down against the isolation window 201a or the isolation wall 201, as the case may be. The alpha seal 19 surrounds the inside of the alpha door 16 and seals the door 16 to the flange 11 upon closure. The installation of the alpha flange 11 is relatively permanent, while the beta flange 101 is often inserted and removed.
FIG. 2D is an elevational view of the alpha assembly 10 viewed from the rear. Alpha bayonet receiver 11a is configured for mating engagement with a beta flange bayonet 101a when the beta assembly 100 is docked with the alpha assembly 10. After initial docking, handles 104a are used to rotate the beta flange bayonets 101a counter-clockwise to releasably lock the beta flange bayonets 101a under the alpha bayonet receiver channel 11b. Alpha door bayonets 16a are also configured for mating engagement with beta cover bayonet receivers 102b. Handles 104a are used to further rotate the docked beta assembly 100 counter-clockwise to rotation of the beta flange releasably lock the alpha door bayonets 16a under the beta cover bayonet receiver channels 102c.
FIG. 2E is an isometric view of the alpha assembly 10 with the alpha door 16 closed. As previously mentioned, latch handle 14 is engaged with latch 13. When latch handle 14 is in the up position it locks latch 13 and thereby alpha door 16. FIG. 2F is an isometric view of the alpha assembly with the alpha door open. To open the alpha door 16, latch handle 14 is rotated counter-clockwise 180°.
FIG. 3A is an isometric view of the beta assembly 100 from the front. As shown in this view, the beta assembly 100 is comprised of three main components: the beta cover 102, beta seal 103, and the beta flange 101. The beta cover 102, including the beta cover end cap 102d provides a closed interior space 100a for the rigid product tube 109 and a rigid drain tube 107 (shown in FIG. 3B). The closed interior space 100a created by the cover end cap 102d is used in the sterilization mode. Sanitary fitting clamp 110 connects a flexible product hose 203 to a rigid product tube 109 for use during the sterilization process and for transfer of product during the filling process. The beta cover 102 is releasably locked to the beta flange by alignment of the beta cover bayonets 102a with the bayonet cover receivers 101b of the beta flange 100, followed by rotation of the beta cover bayonets 102a under the beta cover bayonet receiver channels 101c. Beta flange 101 comprises handles and brackets 104a and 104b, sanitary fitting clamp 110, and flange bayonets 101a. Flange bayonets 101a are aligned with the alpha bayonet receiver 11a during docking of the beta assembly 100 with the alpha assembly 10. Cover seal 103 seals the beta cover end cap 102 to the beta flange 101 when the beta cover 102 is connected to beta flange 101. Handles 104a are used to rotate the beta flange bayonets 101a counter-clockwise to releasably lock the beta flange bayonets 101a under the alpha bayonet receiver channels 11b. Alpha door bayonets 16a are configured for mating engagement with beta cover bayonet receivers 102b. Rotation of the beta flange bayonets 101a counter-clockwise also releasably locks the alpha door bayonets 16a under the beta flange bayonet receiver channels 102c.
FIG. 3B is an exploded, isometric view of the beta assembly 100 from the front. In this view, the interior space 100a of the beta flange can be clearly seen. A first combination of the sanitary fitting clamp 110, the sanitary fitting cap 106, and the sanitary fitting seal 105 provides the connection between a flexible product hose 203 from the product tank 202 and the rigid product tube 109. A second combination of the sanitary fitting clamp 110, sanitary fitting seal 105, and sanitary fitting cap 106 provides the connection between a product tube 109 and a flexible filling hose 208. A rigid drain tube 107 is shown in the interior space 100a and is combined with the sanitary fitting clamp 110, sanitary fitting seal 105, and sanitary fitting adaptor 108. It provides the connection between the interior space 100a of the beta assembly 100, the rigid drain tube 107, and the flexible steam drain hose 207. The rigid drain tube 107 is used during the sterilization process.
FIG. 3C is a elevational view of the beta assembly from the rear. FIG. 3D is a cross-sectional view of the beta assembly 100 of FIG. 3A. FIG. 3D is a cross-sectional view of the beta assembly 100 of FIG. 3A. The product port and the drain port, as shown at the rear of FIG. 3D, are capped with sanitary fitting adaptors 106 for storage of the beta assembly.
FIG. 4A is an isometric view of the product tank 202 with the docking cover 111 located on the product tank. The docking cover 111 may be located on a wall, bench, or other convenient place within the product suite 205. The tank 202 is shown with wheels to indicate that the tank 202 is movable within the product suite 205 or movable to an entirely different product suit. It is typical that the SLTP will include multiple product tanks 202 and beta assemblies 100, yet only one alpha assembly 10. The beta assemblies 100 can also be located in a mobile product suite 205. The flexible product hose 203 is used as steam supply hose during sterilization and for transferring product to the beta assembly during filling. Each hose 203, 207, and 208 attaches to a sanitary fitting adaptor 108 when connected to the beta assembly 100.
FIG. 4B is an isometric view of the beta assembly 100 aligned for docking with the docking cover 111. The docking cover 111 is attached to a mounting plate 200 that in turn is attached to the outside of the product tank 202. The beta assembly 100, beta cover 102, and the mounting plate 200 are not connected in any way to the inside of the tank 202. The docking cover 111 has bayonet receivers 111b for engagement with the beta flange bayonets 101a on the beta assembly 100.
As shown in FIG. 4C, the beta cover end cap 102d is inserted into the docking cover opening 111a, which is in alignment with the mounting plate opening 200a.
After insertion of the bayonets 101a into the bayonet receivers 111b, the beta assembly, as shown in FIG. 4D, is rotated counter-clockwise, using handle assemblies 104, thereby rotating the beta flange bayonets 101a in the docking cover bayonet receiver channels 111c. Sanitary fitting adaptors 108 are also shown.
FIG. 4E is an isometric view of the beta assembly with a flexible product hose 203 and a steam drain hose 207.
FIGS. 4F and 4G are isometric views of the product tank 202 and the beta assembly 100 docked with the docking cover 111 in the steam sterilization mode. Steam from a steam source is introduced into the top of the product tank 202 through the flexible steam supply hose 206. Steam exits at the bottom of the tank 202 through the flexible product hose 203 and into the beta assembly 100 via rigid product tube 109. Steam continues its travel through the interior 100a of the beta assembly 100, out the rigid drain tube 107, through the flexible steam drain hose 207, and into a condensate tank for disposal. FIG. 4G illustrates the detail of the beta assembly interior 100a and the hose connections to the beta assembly 100.
The beta assembly 100 is an integral part of the sterilization process. The sterilization system comprises the interior surfaces of the empty (i) product tank 202, (ii) flexible product hose 203, (iii) flexible steam supply hose 206, (iv) flexible steam drain hose 207, (v) beta assembly 100, and (vi) steam source. The beta assembly 100 comprises the beta assembly interior 100a. The interior 100a, comprises the (i) rigid product tube 109, (ii) beta flange 101, (iii) beta cover 102, and (iv) outlet 107a of the rigid drain tube.
Exposure to elevated temperature and pressure for an extended period ensures sterilization of all of the internal surfaces of the sterilization system. The alpha door 16 of the alpha assembly 10 is closed and sealed while sterilization takes place. Saturated steam at the elevated temperature and pressure is circulated through the sterilization system. The saturated steam is injected through the system at a working pressure of about 36.3 psi (depending upon the product type). The saturated steam temperature is about 150° Centigrade (depending upon the product type) when it enters the system. The required level of sterilization is maintained by continually monitoring the steam temperature at the rigid drain tube 107 to ensure that the steam temperature at the drain tube 107 remains at or about 150° Centigrade (depending upon the product type). After the system is sterilized, condensate is removed from the system by injecting hot, dry air through the system.
Upon completion of the sterilization process the beta assembly 100 is undocked from the docking cover 111 and docked with the alpha assembly 10. During the sterilization process the flexible product hose 203 was connected at the rear of the beta assembly 100 to the rigid product tube 109. To maintain sterilization, the flexible product hose 203 must remain connected. The flexible steam drain hose 207 and the sanitary fitting adaptor 108 must be removed from the rigid drain tube 107 and replaced with the sanitary fitting cap 106.
FIG. 5A is an isometric view of the beta and alpha assemblies 100 and 10 with the beta assembly aligned for docking with the alpha assembly.
FIG. 5B is an isometric view of the beta assembly with the beta flange bayonets 101a received in the alpha bayonet receivers 11a.
As shown in FIG. 5C, the beta flange bayonets 101a are then rotated counter-clockwise under the alpha bayonet receiver channels 11b.
FIG. 5D is an isometric view of the alpha and beta assemblies 10 and 100 with the alpha door 16 latched.
FIG. 5E is an isometric view of the alpha and beta assemblies 10 and 100 with the alpha door 16 unlatched.
FIG. 5F is an isometric view of the alpha and beta assemblies with the alpha door 16 open, thereby allowing access to the sanitary fitting adaptor 108 for attachment to the flexible filling hose 208.
FIG. 5G is an isometric view of alpha and beta assemblies 10 and 100 having one rigid product tube 109. FIG. 5H is an isometric view of the alpha and beta assemblies 10 and 100 having two rigid product tubes 109. In certain cases, two substances may be differentially metered from separate product tanks into the respective product tubes 109 for combination into a two-part medicant. In this manner any number of individual product tubes may be employed to mix the various substances together. In FIGS. 5G and 5H, the rear of the beta cover 102 is captured by the alpha door 16 when the beta assembly 100 is engaged with the alpha assembly 10. The flexible filling hose 208 extends into the filling suite 204.
FIG. 5I is an elevation view of the SLTP in the filling mode.
FIG. 5J is a detailed view of the SLTP in the filling mode. Transfer of product to the filling suite 204 may be accomplished by pumping, gravity feed, or pressurization of the product tank 202. Typically, product is stored under pressure.
As shown by FIGS. 5A-5J, the alpha assembly 10 and the beta assembly 100 implement the process of uncontaminated transfer of sterile liquid product. The product suite 205 is always isolated from the filling suite 204 by an alpha assembly 10. The alpha assembly 10 has an interface for docking the beta assembly 100. The alpha assembly 10 is configured so the alpha door 16 cannot be opened without the beta assembly 100 docked to the alpha assembly 10. This ensures that the product suite 205 will not contaminate the filling suite 204.
To transfer sterile liquid product from the product tank 202 to the filling suit 204, (i) the flexible steam supply hose 206 is shut-off from the product tank 202, (ii) the flexible steam drain hose 207 is shut-off from the sanitary fitting adaptor 108 on the beta assembly 100, the adaptor is removed from the beta assembly, and the adaptor 108 is replaced with a plug; and (iii) the beta assembly 100, with its attached flexible product hose 203, is undocked from the docking cover 111 and docked with the alpha assembly 10. And the product tank 202 is filled with product.
Rotating the beta assembly 100 and docking it to the alpha assembly 10 causes four events to simultaneously occur. First, during docking the beta flange 101 becomes rigidly attached to the alpha flange 11. Second, docking causes the beta cover 102 to become detached from the beta flange. Third, the beta cover 102 whose external surfaces have been exposed to the product suite 205 becomes attached to the alpha door 16. All external surfaces are sealed inside the alpha door 16 by the alpha seal 19. Finally, the docking process disengages the interlock mechanism on the alpha assembly 10 thus enabling the alpha door 16 to be safely opened. Once opened, the beta cover 102 becomes separated from the beta flange 101 thereby exposing the sterile rigid product tube 109, sterile sanitary fitting seal 105, sterile sanitary fitting adaptor 108, and sterile sanitary fitting clamp 110 to the clean filling suite 204. Attachment of a flexible filling hose 208 enables transfer of the sterile liquid without contamination from the product suite 205 into the filling suite 204 and subsequently into the filling equipment 209.
