Monday, July 5, 2021

Dust Management in a Pharmaceutical Environments

 

CDMO pharmaceutical company


Dust Management in a Pharmaceutical Environments

A few of the most familiar unit operations such as sieving, blending, encapsulating, spray-drying, coating, mixing, table-ting, screening, milling, and conveying are processes that can initiate dust. Although dustiness is not a unique issue to the pharmaceutical formulation industry, it needs very close attention.

Various factors need to be considered, such as the prospective effects on the health of workers. Also, cross-contamination and management/retrieval must be thoroughly considered.  

Sovereign Pharmaceuticals is the number one CDMO Pharmaceutical Company in America. We are committed to exceeding quality and regulatory requirements, as well as focusing on our customers. We do this via dedicated, empowered, and motivated employees.


Pharmaceutical Dust

The release of harmful dust materials may transpire during the pharmaceutical manufacturing of products such as orally ingested powders, tablets, pills, or during the equipment cleaning process.

For this reason, one needs to understand various factors such as the physical and chemical characteristics of processed materials and other environmental interactions that may cause cross-contamination.

Other products may be contaminated and can lead to an impact on the safety and quality of products. It can also lead to a high cost of cleaning, resulting in extra downtime and wear of costly machinery.


Managing the Risks of Pharma Dust

1. A very practical approach to dust management is using a product with very low dust potential. Products with lower dust potential are easier to manage as regards the dustiness in the environment.

2. Another effective approach to dust management is ‘Source Capture.’ The ability to capture the dust during its instigation source is a practical approach. This technique involves employing several types of coverings to segregate the dust as close to the point of origin as possible. This is done to safeguard the process operator and stop the airborne dust from moving elsewhere across the facility.

3. Another effective method of dust management is via the use of filtration and extraction systems. Setting up an industrial filtration system will ensure compliance with governing standards of cross-contamination and hazardous issues.


This technique may also involve unique accessories or options to improve the reliability and safety of the filtration system. Through this, the dust-generating process can be contained from the rest of the facility while protecting the contained area.

The achievement of full regulatory compliance is based on the proper use of process instruments and equipment and also testing products both under laboratory conditions and in the work environment.

Achieving full regulatory compliance is based on the proper use of equipment and process instruments and testing both in the work environment and under laboratory conditions.  

Sovereign Pharmaceuticals is a pharmaceutical company in Texas. We stay focused on the customer. We constantly upgrade our facilities and equipment to meet our customers’ demands. We request you to visit our facilities and are open to the opportunity to talk about how we can fulfill your production and development needs. Contact us today.

How to Scale-Up from Lab to Pilot to Production

 

pharma product development


How to Scale-Up from Lab to Pilot to Production


It is one thing to get a pharmaceutical product to perform well in the lab and another thing to get the same result to scale up flawlessly in the production stage. In addition, factors such as altered material properties and different batch sizes can impact the performance of products.


The pilot scale-up technique is helpful to scientists, as it can help them to understand the ultimate potential of a product. In addition, because it can come in handy to know the pitfalls to avoid, we have provided a pathway to follow during this process. Keep reading to learn more about this.


Sovereign Pharmaceuticals is the number one CDMO Pharmaceutical Company in America. We are committed to exceeding quality and regulatory requirements, as well as focusing on our customers. We do this via dedicated, empowered, and motivated employees.


Pilot Scale-Up and the Processes Involved


The pilot scale-up process explains the procedures involved when developing products before formulating the first pilot-production batch. Below, we have highlighted the four primary steps to follow.


1. Choosing the formula

The first step in pilot scale-up in a pharmaceutical formulation is to choose an appropriate preliminary formula. This process will be completed in the development laboratory. Your selected formula should be one you intend to test and know more about based on factors such as initial specifications and design requirements. This formula should be referred to as your (1x) laboratory batch.


In many cases, the initial size of the laboratory batch will be:

* 3 to 10 kg of a semisolid/solid

* 3 to 10 liquid liters

* 3,000 to 10,000 capsule or tablet units


Before creating capsule or tablet units, milling must occur. During this process, the material is broken down into more uniform and smaller particles. After that, developers can compress, mix, compress, and coat the particles into the final unit dosage.


2. Creating the laboratory pilot batch of the drug product

The second step is to make a laboratory pilot batch. This batch will be (10x). Because you are multiplying your first batch by 10 to get a larger scale, your pilot laboratory batch will be:

* 30 to 100 kg of a semisolid/solid

* 30 to 100 liquid liters

* 30,000 to 100,000 capsule or tablet units


Bear in mind that these numbers are not a concrete rule but a standard. In addition, a few factors, such as the cost of your raw materials and the availability of your essential equipment, can alter your laboratory pilot batch.


3. Carrying out Stability Testing

Now that you have prepared pilot laboratory batches and instituted the process demonstration, the third step is to test advanced stability.

During this time, your product should be in its approved packaging instead of standard packaging.


4. Ongoing Pilot Production

The last and final stage is the pilot production phase. During this phase, the batch will scale up to 100x. This means that the batch will become:

* 300 to 1,000 kg of a semisolid/solid

* 300 to 1,000 liquid liters

* 300,000 to 1 million capsule or tablet units


At the end of this phase, the product passes through stability testing in approved packaging.

Sovereign Pharmaceuticals is a pharmaceutical company in Texas. We constantly upgrade our facilities and equipment to meet our customers’ demands. We request you to visit our facilities and are open to the opportunity to talk about how we can meet your production and development needs. Contact us today.

The Vital Role of CDMO Pharmaceutical Companies in Modern Drug Development

The pharmaceutical industry faces unprecedented challenges and opportunities, driven by rapid scientific advances, increasing regulatory com...