Mactus Technology Solutions

Glove Integrity Tester

  • Integrity tester for offline testing of gloves at a glove testing station
  • Testing carried out conforming to ISO 10648-2
  • The method used is Pressure Decay Method
  • It is possible to test two gloves at a time
  • Test report is generated on completion of the test
  • A HMI unit is provided to initiate the test, change set points if needed and to provide feedback on the test progress and result

Dynamic Pass Boxes

  • Dynamic pass boxes including controls
  • Complex control logic can be provided to ensure minimum sterilization time etc
  • Additional intelligence such as record of operations can be provided

Wireless sensor network to transfer data to a central computer

  • Wireless point to point network
  • Data exchange through Modbus protocol
  • 1280 analog signals can be acquired using this network (40 devices each with 32 sensors each)

Software Products

The Manufacturing Compliance Console

Intervention Monitoring and Recording for batch process in pharmaceutical industries :  Stay informed about interventions in the processes – Get control over them and continuously improve processes

Ensuring compliance to operating procedures involves significant efforts in pharmaceutical industries. This is further complicated by the employee turnover, which is a phenomenon no industry segment is exempt from. It is also incumbent upon the management that interventions in the processes are documented, tracked, closed and processes are continuously improved to minimise the interventions into the processes. Stringent practices in the sterile areas make is extremely difficult for the operators to record interventions into the process which they perform and it is not uncommon that actual data of such interventions are lost. While complete automation of manufacturing lines with complete elimination of personnel might be an answer, a balance has to be struck between the level of automation in machines and the deployment of manpower to run the processes and monitor them.

The Manufacturing Compliance Console (MCC) helps in this endeavour. MCC is a system built of the following:

This system records all the deviations through simple touch mechanism on a console to fulfil the requirement that all the actions taken by the operator from the time the filling/sealing machine doors are opened till the time they are closed from the time of batch start to the time of end of batch. The record so generated can be filed with the BMR as an evidence of compliance to operating procedures.

The information collected can also be later analysed to effect improvement actions, by applying classical Quality Management Tools, Six Sigma tool kit and so on. MCC is designed to make adherence to procedures a routine and to sustain manufacturing compliance over long periods of time. Over a period of data analysis and improvement actions thereof should result in total elimination of unwarranted interventions/deviations or very few instances far between in time.

Operations:

The MCC is operated by a supervisor observing the process from a non-sterile area either directly or through a system of video cameras.

The tablet computer runs a dedicated application to continuously collect and record all the instances of machine stoppage, door opening etc, which signal interventions in processes. The supervisor then observes the actual intervention the operator performs and chooses it from a list of standard interventions. The intervention details are recorded with timestamp. The supervisor can also record additional comments to clarify/explain the actions. All events are printed instantly on the printer. When an intervention is recorded, it is announced to the operator in the sterile areas through speaker system. Additionally the supervisor operating the console will have facility to communicate with the sterile area operator using a microphone.

A visual indicator is also provided both inside and outside the sterile areas to draw the attention of the machine operator or MCC operatoe whenever an audio message is being broadcast.

Deviations observed are recorded in the hard disk in the MCC and can be printed later should the need arise.

Electronic Batch Manufacturing Record (E-BMR):

  • A digital representation of BMR
  • Maintained through computer/laptops/ tablet computers by the different actors
  • Closely documents workflow
  • Data collected directly from the manufacturing equipment

E-BMR System

  • A workflow and data archival system
  • Web enabled system
  • Operated from anywhere in the plant
  • Various devices can be used (PCs, laptops, tablets)
  • 21 CFR Part 11 compliant
  • Reports in non-editable PDF
  • Non-editable audit trails
  • Alerts through e-mail, SMS
  • Can integrate with ERP systems
  • Integration with systems if already implemented
  • Deviation management
  • Instrument calibration and validation
  • Learning Management