Hygrometers are important devices in the pharmaceutical world as it measures the relative humidity of the atmosphere, which can affect the products during the manufacturing process. The device includes two thermometer – the dry and the wet bulb. The dry bulb remains dry while a cotton wick that is dipped in water surrounds the wet bulb. In the measurement of humidity, the wet bulb plays an important role.
The buffer area is the space or area in the manufacturing facility where sterility of the area is strictly implemented. A compounding area in a pharmaceutical facility is known as the buffer area and is classified as ISO 7 area or class 10,000 with excellent air quality.
The principles of GMP are a follows, the structure, device and equipment should be designed, installed, placed, operated and maintained as per its intended use and purpose. Integral system whose consistency in performance and having an impact to product quality should be validated whenever appropriate such as the air handling system, water purification, compressed air system and stem system.
A Mix–Up may be defined as:
- An unplanned combination of various compounds.
- A mistake brought about wrongly identifying one material for another.
A mix-up can be caused by bad judgement or lack of attention to detail, i.e., human error. It can also occur though poor communication between personnel.
First discovered in 1928 by Alexander Fleming, penicillin is now one of the most common drug used to help cure patients from bacterial infections. The beta lactam ring of the penicillin is the one responsible for the drug’s anti-microbial activity, which many of the antibiotics medicine have.
The packing process is an integral part of the manufacturing process for pharmaceutical products. Below is a summary of good practices that may help streamline the packing process.
A standard operating procedure (SOP) is a written instruction describing how a routine task is to be carried out; when, where and by whom. SOPs play a fundamental role in continuous quality assurance and ensuring best practice for your company, in order to assist you in protecting the safety of your patients and members of the public. The implementation of SOPs, which are specific to your production facility, will help you to:
Most tray dryers used in the pharmaceutical industry comprise a heated cabinet in which a rack of trays is located. They are frequently used for the drying of granulated powder. Heat can be provided by burning a fuel, e.g. natural gas or, more usually, by one or more electric elements located within the cabinet, together with a blower to circulate the air.
To ensure consistent high quality of tablet production it is necessary to inspect each and every tablet produced by a tableting machine. Machines have been available for many years that can assist in the manual inspection of tablets. These feed the tablets from a chute onto a conveyor that vibrates or rotates the tablets through 360 degrees so that physical defects can be identified by an operator.
Most recently with the introduction of digital image recognition technology and software, machines are available that can automatically identify and reject tablets that have defects. For either manual or automatic inspection machines, it is essential that the equipment is thoroughly cleaned before starting the inspection of any new batch of tablets. The following is a brief guide that can be applied to the operation and cleaning of most tablet inspection machines.
Pre Start Up
- Check that the area in which the inspection machine is located and ensure that the machine is clean, and there are no remnants of previous products in the area or in the equipment.
- Check the relative humidity and temperature of the work area and document it in the logbook.
- If the temperature is not within the allowable limits, inform the maintenance, department and do not start the operation.
- If temperature is within limits, start the inspection operation.
- Ensure that the equipment is correctly labelled for the particular batch of product.
- Get line approval from Quality Assurance (QA) department to start the process.
- Switch the mains electricity ON.
- Check for any abnormal noise by pushing the start button.
- To collect the inspected tablets, place a tared polythene lined duly labelled high-density polyethylene container below the machine’s discharge chute.
- Place the required batch of tablets into a trolley and place trolley near the inspection machine.
- Manually feed the tablets to the machine’s hopper.
- Set the vibration or rotation of the conveyor as required.
- Switch on the conveyor belt.
- In the case of manual inspection, check for any defects on the tablet as the move along the conveyor.
- Collect the recoverable rejected tablets from the rejection box and place into a polyethylene container.
- When the container at the discharge chute fills up, replace it with a similar container.
- Remove the container and close the bag with a tie band, and place it in a different trolley to the product.
- When the tablet inspection is complete, switch the machine off.
- Isolate the main electricity supply.
- Move the product tablets to the intended placement area.
- Remove the machine status label and dispose of it.
- Place a “to be cleaned” label on the machine.
- Remove the “to be cleaned” and tear the label after checking the information on it.
- Clean the machine hopper and conveyor belt using lint free cloth dipped in purified water.
- Send a rinse sample to the in-process QA department.
- Clean the machine with line free cloth dipped in purified water and dry with lint free cloth.
- Clean the equipment body with dry lint free cloth.
The following is a brief operating and cleaning guide that can be used for most tablet de-dusting machines. It covers pre-start up, operation and cleaning, and lists some precautions that can be taken to help avoid contamination issues.