DESC:PRIORITY CLAIM:
[0001] This application claims priority from the provisional application numbered 201941009467 filed with Indian Patent Office, Chennai on 12th March 2019 titled “An access control system to enable Good Manufacturing Practices (GMP) in aseptic areas”, the entirety of which is expressly incorporated herein by reference.
Preamble to the Description
[0002] The following specification particularly describes the invention and the manner in which is it be performed:
DESCRIPTION OF THE INVENTION
Technical field of the invention

[0003] The present invention relates to an access control system, as a part of good manufacturing practices in an aseptic area. More particularly, the invention provides a system for restricting the number of operators entering the aseptic area by denying access to authorized operators once the specific limit of operator within the aseptic area is reached and also denies access to the unauthorized operators.
Background of the invention
[0004] Good manufacturing practices (GMP) adhere to a systematic approach that assures proper design, monitoring and control of manufacturing processes and facilities. GMP establishes an adequate control system in manufacturing operations, which assures the identity, strength, quality and purity of drugs. GMPs provide a strong quality management system and are employed to implement a broad modern quality system and a risk management approach in a pharmaceutical industry.
[0005] Generally, maintenance of aseptic areas is critical in ensuring GMP during drug manufacturing as even minimum level of contamination in the area may result in adulteration of the whole batch of drugs being manufactured. A well-designed aseptic area minimizes personnel intervention and ensures product sterility, while restricting entry only to trained personnel thus optimizing the production process.
[0006] GMP regulations ensure that record maintenance, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling are performed as well as tracked systematically.
[0007] One of the requirements of good manufacturing practices is limiting the numbers of operators working in the aseptic areas. Further, all the operating systems in the pharmaceutical manufacturing areas have a regulation to maintain electronic records and electronic signatures as they are considered more trustworthy and reliable over manual records. However, the existing access control systems fail to meet these requirements. The pharmaceutical manufacturing companies maintain manual registers and track the number of operators present in an aseptic area.
[0008] The objective of an access control system is to restrict the entry of operators into a property, building, zone or any confined area and determines the entry and exit of select operator based on the valid credentials being presented at the entry point.
[0009] Traditional access control systems don’t have a feature to deny access to an operator if the area exceeds the maximum permitted count, which is an essential attribute of an aseptic area, wherein only limited numbers of operators are required to be present inside the premise. Further, the available systems do not alert the operator before exceeding the permitted duration in an aseptic area or when an operator overstayed in an aseptic area. Authorization to enter a premise is usually based on access card, password, finger print or any other biometric methods. Few of the prior art pertaining to restricting access to specific areas and the method of monitoring deviation are discussed below:
[0010] The US application numbered US3866173A titled “Access control system for restricted area” discloses an access control system for controlling the entry and exit of personnel through a door or a gate of a restricted area. A person can enter the restricted area after presenting the personnel identification card containing magnetically encoded data into the card reader located outside the restricted area, followed by entering a secret number on a keyboard. The system performs checks on the card and keyboard data to determine if the person is authorized to enter. If all the checks are passed satisfactorily, the door is opened and the person can enter the restricted area. A written record of each attempt is made by a printer providing a chronological record of all system events. The system also prevents persons in a defined group from entering a restricted area, the system also prevents entry by selected individuals. This system also comprises a card erase mechanism where only the magnetically encoded data of several unsuccessful attempts will be deleted, but the card can be used by the person for other purposes as printed and photographic information are included on such cards. The access control system also includes egress monitoring in the form of a printed record of personnel egress from the restricted area, the egress monitoring becoming active when the individual leaves the restricted area and allows the door to close behind him.
[0011] The US application numbered US6154133A titled “Exit guard system” discloses an exit guard system, which automatically detects movement of a subject along an exit path in an unauthorized direction. Two video cameras are used such that the first video camera is positioned for video imaging movement along the path, while second video camera images the subject for movement in reverse direction. Multiple video motion detectors operate parallel with the first video camera to detect direction of movement of the subject. A CPU operates with the video motion detectors to provide a watching mode, during which frames of the second video camera are continuously recorded and saved. An alarm signaling devices are operated by the CPU to alarm the subject in case of movement in unauthorized directions. A video monitor displays mode of operation of the system and control devices allow operator selection and control of modes of operation of the system. The remote access to the system for control and monitoring are provided by data modem feature.
[0012] The US application numbered US11437461 titled “Automated tailgating detection via fusion of video and access control” discloses an automated tailgating detection system for an entry through a door or entry port, including an entry authorization sensor detecting valid entry credentials and transmitting the number of valid entry credentials detected. An automated video surveillance system detects, counts and tracks the persons entering through the door. The processor receives the number of valid entry credentials and verifies with number of people detected through video surveillance and signals an alarm when the credentials number is less than the actual number of persons detected. A door contact sensor determines the state of the door, i.e. when the door is opened and closed and sends a signal.
[0013] Hence, there is a need for a system to overcome the limitation existing in the available access control systems, and to design a control system, which limits the entry to only authorized personnel along with limiting the number of operators working in the aseptic areas.
Summary
[0014] The invention overcomes the drawbacks of the existing prior arts by providing an access control system with high level of scrutiny and equipped to authorize and limit the number of operators working in the aseptic area by restricting their entry to the aseptic area.
[0015] The invention provides a system for restricting the number of operators entering an aseptic area, the system restricts entry even to authorized operators and denies access to unauthorized operators. The system comprises tracking devices such as a biometric reader to record entry and exit along with authenticating the operator at an entry door and also at an exit door. The biometric readers are further connected to a master console to authorize and record such operations, multiple change rooms are provided where access through the change rooms in the entry module en route to the aseptic area is also controlled with a push button enabled entry door, along with controlled access through the multiple exit change rooms en route to exit from the aseptic area in the exit module. The system also comprises an aseptic area provided with consoles to record and monitor the entry and exit operations as well as batch progress within the aseptic area. The entry and exit module comprises at least two push buttons each to operate the doors of the change room, a network hub connected through a Local Area Network (LAN) to connect the multiple consoles to a Programmable Logical Controller (PLC) which is configured to control, monitor and signal various operations of the access control system.
[0016] Additionally, the doors are operable for ingress and egress of material and also during cleaning the aseptic area by choosing the indicated purpose at the master console. The PLC is also configured to permit entry and exit during such operations.
[0017] The first biometric reader present at the first door of the entry module validates the user credentials and records the purpose of entry to the aseptic area using a touchscreen interface. Further, entry is permitted only if the number of operators working in an aseptic area is within the permissible limits. The biometric reader is disabled once the number of operators in an aseptic area exceeds the specified limit. The valid entries of operator along with entry time are recorded in the electronic register of the PLC.
[0018] The system also warns the operator of overstaying and also records deviations such as entry and exit tailgating. The user credentials are recorded at the exit biometric reader of the exit door, in case the operators doesn’t provide the credentials at the exit biometric reader, the exit is denied, and suitable warning is displayed at the exit. An alert console within the aseptic area records deviation of a batch.
[0019] The invention has an advantage of monitoring entry and exit of operators within the aseptic area along with recording entry and exit tailgating. The system provides restricted entry to authorized operators and denies access to unauthorized operators thus limiting the number of operators working in the aseptic area.
Brief description of drawings
[0020] FIG 1 illustrates a system for access control along with the systematic entry and exit procedure applicable in the aseptic areas.
Detailed description of the invention
[0021] Reference will now be made in detail to the description of the present subject matter, one or more examples of which are shown in figures. Each example is provided to explain the subject matter and not a limitation. Various changes and modifications obvious to one skilled in the art to which the invention pertains are deemed to be within the spirit, scope and contemplation of the invention.
[0022] The invention discloses an access control system to enable Good Manufacturing Practices (GMP) in aseptic areas. More particularly, the invention provides a system for restricting the number of operators entering an aseptic area and denying access even to authorized operators when the permissible limits within the aseptic area are exceeding along with denying access to unauthorized operators.
[0023] The system comprises a tracking device such as a finger print reader or any other biometric reader such as reader for face detection or iris detection, which automatically tracks the entry and exit operations.
[0024] FIG 1 illustrates a system for access control along with the systematic entry and exit procedure applicable in the aseptic areas. The system (100) comprises a controlled entry module to allow entry through at least two change rooms en route to an aseptic area, a controlled exit module to exit from the aseptic area through at least two change rooms and monitoring systems to control exit and entry operation.
[0025] The entry module (100a) further comprises, a first door (101) operable through an entry biometric reader (112) to permit entry to a first change room R1 (121), the first door (101) is also operable with an exit biometric reader (112a) to exit from the first door (101) of the first change room R1 (121), a second door (102) operable with a push button (113) to permit entry to a second change room R2 (122) and a push button (113a) to permit exit from the second change room R2 (122) from the second door (102), a third door (103) operable with a push button (114) to permit entry to the aseptic area (125) and a push button (114a) to permit exit from the aseptic area (125) through the third door (103).
[0026] The exit module (100b) comprises a fourth door (104) operable by a push button (110) to exit from the aseptic area (125), a fifth door (105) operable with a push button (115) to exit from a third change room R3 (123), a sixth door (106) operable with an exit biometric reader (111) to exit from a fourth change room R4 (124).
[0027] The entry and exit activities are closely monitored and controlled by operation comprising a master console C1 (107), an alert console C2 (108), and a recording console C3 (109), a Local Area Network (LAN) (116 and 117), a Programmable Logic Controller (PLC) (118), a network hub (119), a control signal (120) for door lock open and close mechanism by the PLC (118).
[0028] The first door (101) is connected to the entry biometric reader (112), which is further connected to the master console C1 (107) through the LAN (116 and 117). The connections from the master control C1 (107) and biometric reader (111), (112) and (112a) are further connected to the network hub (119), controlled by the PLC (118) system.
[0029] Alternatively, an embodiment of the system for functioning of the master console C1 (107) and the PLC (118) system is combined into a single controller unit.
Example 1: Depicting the systematic entry to the aseptic area
[0030] The entry module (100a) provides controlled monitoring and recording of events of the operators while entering the aseptic area (125).
[0031] The system comprises the first door (101) operable through the entry biometric reader (112). The entry biometric reader (112) authenticates the operator’s credentials and records the purpose of entry through a touch screen interface, which is a part of the master console (107). The operations are recorded in the master console C1 (107), through LAN (116 and 117). The application in the master console C1 (107) authenticates additional conditions, such as training validity and hygiene checks or health conditions based on the information available in the database of the PLC (118).
[0032] Further, if the existing count in the aseptic area (125) is within the permissible limit, the PLC (118) having the control signal (120) for door lock open and close mechanism, operates to provide access to the operator at the first door (101) to enter the first change room R1 (121), followed by incrementing the existing count of operators in the aseptic area (125) and updating the same along with recording the time of entry in the electronic register of the PLC (118). Once the number of operators working in an aseptic area (125) reaches the maximum limit, the PLC (118) disables the entry biometric reader (112) thereby restricting entry even to an authorized operator.
[0033] Further, the system (100) comprises the second door (102) operable by the push button (113) to enter the second change room R2 (122). The third door (103) to enter the aseptic area (125) is operable by the push button (114). The push buttons are controlled by the PLC (118) connected through the control signals (120), for door lock open and close mechanism and provides signals for unlocking of doors. Upon entry to the aseptic area (125), the operator is able to record any interventions in a batch using the alert console C2 (108).
[0034] In case, an operator exceeds the permitted time limit within an aseptic area (125), the system is configured to send alert signals to the overstaying operator to exit the premise. Overstay alert is also sent to the manager and supervisor, which is reset by the manager. Further entry of such operator is also disabled. The overstay alerts sent to such operators are either an audio signal or messages on a display unit or a flashing light or a combination of any of the signals.
Example 2: Depicting the systematic exit from the aseptic area
[0035] The exit module (100b) provides controlled monitoring and recording of exit operations of the operators from the aseptic area (125). The exit module comprises the fourth door (104) operable through the push button (110), to exit from the aseptic area (125).
[0036] The next exit door is the fifth door (105) operable through the push button (115) to exit from the third change room R3 (123) and the sixth door (106) to exit from the fourth change room R4 (124), where the operator authenticates his credentials at the biometric reader (111). The authorized person at the sixth door (106) approves the exit of the operator by entering the operator’s credentials within a time period of 30 seconds and upon completion of exit formalities, exit is approved.
[0037] Such exit operations are signaled to the master console C1 (107) and upon completion of all the exit formalities, the existing count of operators in the aseptic area (125) is decremented from the electronic register of the PLC (118). The PLC (118) approves exit by unlocking the sixth door (106) using the control signal (120). In case an operator tries to exit without providing the valid credentials at the exit biometric reader (111), warning signals are displayed at the sixth door (106).
[0038] Further, deviations such as entry and exit tailgating are recorded in the PLC (118).
[0039] The door layout as shown in FIG 1 is only a sample layout. The actual layout is not restricted as specified in FIG 1 but differs based on the requirement and the plant layout located at the facility.
[0040] An embodiment of the invention may optionally have more than three change rooms with more than three access control doors for entry to the aseptic area and more than three change rooms with more than three access control doors for exit from the aseptic area. The functioning of the such additional doors is further regulated by additional push buttons at such entry and exit change room doors. However, the functioning of the control system along with the parameters and the scrutiny levels remains the same.
Example 3: Depicting the operations functional during the surface cleaning of change rooms.
[0041] Some class of operations, mainly cleaning, may requires access to the change rooms. In such circumstances, the cleaning operator cleans the rooms without entering the aseptic area (125) and doesn’t require to follow the exit procedure. The purpose of entry needs to be provided during such operations at the touch screen enabled biometric reader (112) near the first door (101) connected to master console C1 (107) to record the purpose of entry. The application in the master console C1 (107) signals to the PLC (118) connected through the LAN (116 and 117). The PLC (118) having the control signal (120) for door lock open and close mechanism signals to unlock the first door (101), to allow entry to the first change room R1 (121). The push button (113) is operable to enter through the second door (102) of the second change room R2 (122). Upon completion of the cleaning, the operator exits from the second change room R2 (122) using the push button (113a). The PLC (118) signals to unlock the second door (102) through the control signal (120) to exit from the second door (102). Further, the operator authenticates credentials for exit at the biometric reader (112a) present in the first change room R1 (121) to exit from the first door (101). The completion of cleaning events are recorded in the master console C1 (107). Likewise, cleaning of change rooms R3 (123) and change room R4 (124) are also carried out.
[0042] Example 4: Depicting operations such as entry to aseptic area and exit from aseptic area during fogging.
[0043] An operator executing the fogging of aseptic area (125) and the change rooms (121, 122, 123 and 124) is required to first select the fogging mode in the master console C1 (107) to gain access to the aseptic area (125). An implementation to the control system to operate during fogging mode is also set from recording console C3 (109). The fogging mode is used to facilitate cleaning of the aseptic area (125) and the change rooms (121, 122, 123 and 124). The fogging mode disables the exit and entry door lock, for free movement from one change room to another room to facilitate fogging operation.
Example 5: Depicting operations such as entry and exit for transporting garments and aseptic materials.
[0044] An additional application, requiring transport of garments and other wearables such as aseptic material to the aseptic area (125) requires the operators to enter the second door (102) and the third door (103) or additional doors if present based on the number of change rooms en route to the aseptic area (125) for transporting the aseptic materials. The operator in such case enters through the entry pathway (100a) by providing the purpose of entry at the touch screen interface of the biometric reader (112) connected to master console C1 (107). The first door (101) is unlocked by the control signal (120) from the PLC (118) connected to the master console (107) through the LAN (116 and 117) to enter the first change room R1 (121). Further, to enter the second change room R2 (122), the push button (113) is operable to open the second door (102). The entry to the aseptic area (125) is possible by operating the push button (114) to open the third door (103). Once the materials are transported to the aseptic area (125), the operator either follows the exit module (100b) to exit from the aseptic area (125) or alternatively, exit from the aseptic area (125) is possible by operating the push button (114a) present in the aseptic area (125) to open the third door (103). The operator further exits from the second change room R2 (122) by operating the push button (113a) at the second door (102). The final exit is possible through the biometric reader (112a) present in the first change room R1 (121) to provide the operators credential before exiting from the first door (101).
[0045] If the implementation of such operations are not possible in certain plant layout, then the movement to the change rooms are authorized by privileged users at console C1 (107).
[0046] All the functionalities of the access control system are achieved with a set of biometric readers and with a control system either comprising of a desktop system and a PLC or achieved employing an embedded controller. The embodiments are further designed to be implemented for multiple production lines controlled by a single control system. Additionally, the number of doors in the entry and exit pathway depends on the areas and the level of scrutiny required and does not limit to the mentioned embodiments of the invention.
[0047] The invention provides a systematic functioning for controlled operations of the access control system, which is otherwise not found in the existing access control systems. Further, certain features are designed to ensure utmost scrutiny to provide a secured access control system. The system is designed for maintaining an optimal environment in an aseptic area and as a mandate to include the GMP in pharmaceutical manufacturing units.
,CLAIMS:We Claim:
1. An access control system to enable Good Manufacturing Practices (GMP) in aseptic areas, the system (100) comprises:
a. a controlled entry module (100a) comprising plurality of entry doors (101, 102 and 103) to enter two or more entry change rooms (121 and 122) operable by a one or more biometric readers (112 and 112a) or push buttons (113 and 114) connected to the doors (102 and 103), wherein,
i. an entry biometric reader (112) validates and permits entry through a first entry door (101) to enter a first change room R1 (121) and a push button (113) to unlock a second door (102) to enter a second change room (122), a push button (114) to unlock the third door (103) and a master console C1 (107) to record the purpose of entry via a touch screen based interface of the biometric reader (112);
b. an aseptic area (125) comprising an alert console (108) to record deviations or interventions in a batch and a recording console (109) to signal overstay of operators and record exit tailgating;
c. a controlled exit module (100b) comprising plurality of exit doors (104, 105 and 106), to exit from one or more exit change rooms (123 and 124) operable by plurality of push buttons (110 and 115) and an exit biometric reader connected to the exit door, wherein,
i. a fourth door (104) to exit from the aseptic area (125) is operable by a push button (110), a fifth door (105) at the exit change room R3 (123) is operable by a push button (115), a sixth door (106) at the exit change room (124) is operable by an exit biometric reader (111); and
d. a network hub (119) to collect the data, a Programmable Logic Controller (PLC) (118) connected to the plurality of consoles and tracking devices through a Local Area Network (LAN) (116 and 117) and has a control signal (120) for door lock open and close mechanism, wherein
i. the biometric readers (112, 112a and 111) and the push buttons (110, 113, 113a, 114 and 114a) regulate locking and unlocking of the doors to enter and exit the aseptic area (125), regulated by the PLC (118) connected to master console C1 (107), and further connected to the alert console C2 (108) and the recording console C3 (109) of the aseptic area (125) through LAN (116 and 117).
2. The access control system as claimed in claim 1, wherein said PLC (118) connected to the biometric reader (112) is configured to authenticate and validate the operator’s entry, thus permitting restricted entry to the aseptic area (125), wherein said PLC (118) disables the biometric reader (112) on reaching the maximum permissible limit of operator in the aseptic area (125).
3. The access control system as claimed in claim 1, wherein said master console (107) records authorized entries at the biometric readers (112 or 111), increments or decrements the operators count in the aseptic area (125) based on the entry or exit and updates in the electronic register of the PLC (118).
4. The access control system as claimed in claim 1, wherein said exit biometric reader (111) verifies and signals the recording console C2 (109), to approve exit, wherein, the master console C1 (107) approves and signals the recording console C2 (109) to permit exit.
5. The access control system as claimed in claim 1, wherein said sixth door (106) restricts the exit of the operator by providing suitable warnings during unauthorized exit.
6. The access control system as claimed in claim 1, wherein said system (100) is configured to operate during cleaning, transport of garments and aseptic materials and fogging, wherein said purpose is recorded at entry biometric reader (112) and the entry and exit though doors are configured for said operations.