Capsules are popular and commonly used in the pharmaceutical industry, not only is it easy to manufacturer but it do not need any complex formulation unlike other drug containers.
A single station tablet press is a simple mechanical machine that can be used to compress powder into tablets that are uniform in size, shape and weight. The machine is used for low-volume production of tablets for a wide range of applications from cosmetics and pharmaceuticals to cleaning products.
Despite being an important part to the product’s success, the shape of the tablet is given less consideration by marketing departments and are only given much attention during a campaign where the shape and color of the tablet is promoted to the public. That said, small changes in the shape can impact the public’s acceptance as well as the tablet’s efficiency.
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.
The rules have changed when it comes to development of products in the pharmaceutical, health and nutritional industry. As generic and branded companies in the industry struggle with new products while at the same time addressing the need of new patients, the companies must also meet the growing productivity demands in the manufacturing industry.
A rapid mix granulator is a multi-purpose mixer/processor equally suitable for high speed dispersion of dry powders (including effervescent powders) and their granulation with aqueous or organic solvents. The equipment is designed to achieve rapid mixing and the formation of consistent granules required for the production of high quality pharmaceutical tablets for solid dosage forms of medication. Good mixing and control of granule size leads to fast tableting speeds and high quality products with low rejection rate.
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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:
It is crucial that pharmaceutical companies protect their light sensitive products from direct sunlight or certain spectrums of artificial light. One way to protect it is to use brown colored light especially during manufacturing.
To prevent any contamination to the processing area or inside the building, it is important to learn the procedure for changing clothes during entry and exit through the company’s changing areas.
Color-coding can identify the personnel and their department. Color-coding for the first change room and primary change room is as indicated below:
In this short article we state the guidelines to follow during the online and offline packing for pharmaceutical companies.
1) Ensure that anyone moving the press is wearing the correct protective clothing. This may include:
- Steel toe boots
- Heavy duty grip gloves
- Back support belt
There are several ways to prevent cross contamination during production and below are some ways to do so. Before starting, line clearance should be performed as per the SOP of the company. Do a checklist and record. Check to see if any starting materials are missing, previous record documents, product residues and product itself. Practice a closed system when handling the materials.
With a bigger move towards clean label LFA is seeing less and less use of chemicals in its customers products. Sometimes though it is impossible not to have to use a preservative when undertaking wet granulation.
Batch manufacturing record or BMR is a document that contains the batch manufacturing details including the entire manufacturing process. As there are several stages in the manufacturing process, these are recorded as proof of the process from receiving the raw materials up to the final phases of packing. The proof and the documents are then attached to the BMR during the manufacturing process.
The URS or User Requirement Specification is a document that contains buyer’s requirements concerning the equipment that they would like to purchase. The Equipment User Department prepares the URS and then sends it to the equipment manufacturer to follow. There are some points to consider when making the URS for pharmaceutical companies.