Services

What is so Unique about PsiZen:

PsiZen stands out in the field of pharmaceutical manufacturing due to our ability to effectively handle the unique challenges that come with:

Sifting

Sifting is a fundamental process in pharmaceutical manufacturing with significant importance in ensuring product quality, safety, and compliance with regulatory standards. Through our efficient sifting solutions, we ensure particle separation with accuracy, leading to higher yields and product uniformity. We have used our vast experience in separation technology to resolve the following pain points experienced by our clients:

Addressing sieve blinding: By using anti-blinding devices, selecting appropriate sieve materials, and adjusting vibration intensity or frequency.
Preventing particle aggregation: Controlling the sifting process parameters, such as vibration intensity and duration, to ensure gentle handling of the material.

Inconsistent particle size distribution: Optimizing the sifting process parameters and ensuring the sieves are clean and in good condition.
Achieving accurate and reproducible particle sizing: Regular calibration and validation of the sifting equipment, as well as using quality sieves, can
help achieve accurate and reproducible particle sizing.

Managing cross-contamination risks: Managing cross-contamination risks by using specialised sieves, establishing a cleaning and sanitizing protocol and using dedicated equipment for highly potent or sensitive materials.

Selecting appropriate sieve mesh size and material: Based on the specific particle size distribution and characteristics of the material being
sifted.

Controlling dust generation: By using dust containment systems, ensuring proper seals, and employing exhaust ventilation during sifting.

Handling static electricity build-up: Identifying the sources of Static charges & providing solutions to control them. Static Dissipative materials can be used to reduce static electricity build-up on the sieves and prevent particle adhesion.

Preventing material leakage or loss: Proper design and installation of the sifting equipment and using seals can help prevent material leakage or loss.

Compliance with regulatory requirements: Ensuring adherence to cGMP guidelines and other relevant regulations to ensure product quality and safety.

Overcoming challenges with cohesive materials: Using appropriate sieve designs and anti-blinding techniques to help overcome challenges with
cohesive materials.

Evaluating sifting effectiveness: The effectiveness of the sifting process is evaluated through regular sieve analysis and particle size distribution testing.

Addressing sieve integrity and stability: Regular inspection and maintenance of the sieves to address issues with sieve integrity and stability.

Validating the sifting process: Verifying and documenting that the sifting process consistently to ensure the desired quality and meets regulatory requirements.

Managing the risk of sieve overload: Proper load monitoring and using equipment with appropriate capacity help manage the risk of sieve overload

Milling Solutions

Our precision-focused milling solutions cater to the specific particle size reduction needs of your pharmaceutical products, ensuring consistent quality and enhanced performance. With our profound expertise in pharmaceutical manufacturing, we have successfully tackled a wide array of milling challenges. Some of the key areas we specialize in include:

Precise Particle Size Control: We excel at achieving uniform particle size distribution during the milling process, ensuring consistent product quality and maintaining overall product consistency.

Contamination Prevention: Our stringent protocols and advanced technologies mitigate the risk of contamination and cross-contamination
issues in milling equipment and processes, safeguarding the integrity of your pharmaceutical products.

Heat Generation Management: We understand the criticality of controlling excessive heat generation during milling to preserve the stability of
pharmaceutical compounds. Our innovative approaches ensure optimal heat dissipation and temperature management.

Tailored Equipment Selection: Leveraging our in-depth knowledge, we design best practices for selecting the most suitable milling equipment and
techniques tailored to your specific pharmaceutical formulations.

Enhancing Efficiency and Productivity: Our strategies optimize manufacturing processes to maximize milling efficiency and productivity, streamlining your operations and reducing production costs.

Overcoming Agglomeration and Caking: With a focus on hygroscopic materials, we employ specialized measures to prevent issues like particle
agglomeration or caking during milling, ensuring consistent and smooth processing.

Compliance with Regulatory Standards: We adhere to strict cGMP (current Good Manufacturing Practices) guidelines, ensuring that the milling process meets all regulatory requirements and maintains the highest quality standards.

Expert Troubleshooting: Our seasoned team is well-versed in identifying and addressing milling-related problems, such as equipment malfunctions,
inconsistent particle sizes, or formulation-specific challenges, ensuring minimal disruptions to your production.

Wet Granulation Solutions

Wet milling is performed to reduce particle size and disperse the drug and excipients in the granulation liquid, creating a homogeneous wet mass. We
offer help in resolving the common problems faced during wet granulation:

Agglomeration: Wet milling can sometimes cause particle agglomeration, leading to the formation of lumps or clusters of particles that can be
challenging to break apart.

Inadequate Wetting: Ensuring uniform wetting of all powder particles can be challenging, leading to regions of the mixture that remain dry and poorly
granulated.

Poor Dispersibility: Some drug substances or excipients may have poor dispersibility in the granulation liquid, resulting in incomplete wetting and
uneven distribution of components.

Insufficient Mixing: Inadequate mixing during wet milling can lead to content uniformity issues and variability in the final granulation.

Temperature Sensitivity: Some heat-sensitive drug substances may undergo degradation due to the heat generated during wet milling.

Equipment Compatibility: The wet milling equipment used should be compatible with the formulation components and not introduce any unwanted
contaminants.

Particle Size Variation: Achieving consistent and uniform particle size distribution can be challenging, leading to issues with drug content uniformity
and product performance.

Material Loss: Wet milling can result in material loss due to adhesion to the milling equipment or transfer surfaces.

Drying Difficulties: After wet milling, the granules need to be dried properly. Poor drying can lead to uneven moisture content and affect the stability and quality of the final product.


To overcome these problems during the wet milling step we can help pharmaceutical manufacturers to carefully select the appropriate wet milling
equipment, optimize process parameters, and implement effective quality control measures. Regular testing, validation, and monitoring of the wet
milling process are essential to ensure the production of high-quality granules for further processing and final pharmaceutical products.

Dry Granulation Solutions

Direct granulation by roll compaction is a dry granulation method that involves compacting and densifying the powder material between two counter-rotating rolls to form flakes, which are then granulated into desired particle sizes.

Milling of roll compacted materials involves breaking down the compacted flakes into granules of the desired particle size. While this process is
essential to achieve the final product specifications, several problems can be encountered during the milling of roll compacted materials. Some of these problems include:

Excessive Fines: Milling roll compacted materials can lead to the generation of excessive fines, which can impact product uniformity and flow properties.

Inconsistent Particle Size Distribution: Achieving a consistent and narrow particle size distribution during milling can be challenging, affecting content
uniformity and dissolution rates.

Particle Agglomeration: The milled particles may agglomerate, leading to poor flow properties and difficulties during subsequent processing steps.

Over-Milling or Under-Milling: Over-milling can result in particle size reduction beyond the desired range, affecting compressibility and tablet
properties, while under-milling may lead to incomplete granule disintegration.

Particle Attrition: Milling can cause excessive particle attrition, leading to increased levels of fines and reduced product yield.

Heat Generation: High-speed milling processes can generate heat, potentially affecting the stability of heat-sensitive materials.

Screening Challenges: Some materials may be difficult to screen after milling due to their tendency to blind or block the sieve mesh.

Loss of API Potency: Overmilling can cause degradation of the active pharmaceutical ingredient (API), leading to a loss of potency.

Electric Static Buildup: Electric static charges can accumulate during milling, causing particle adhesion and handling challenges.

Product Loss: Fine particles generated during milling can become airborne, leading to product loss and material waste.

Caking and Hardening: Milled materials may be prone to caking or hardening due to moisture absorption or exposure to atmospheric conditions.

Contamination Risks: If the milling equipment is not thoroughly cleaned between different materials or batches, cross-contamination may occur.


PsiZen Technologies can help you address these problems by careful process optimization, equipment maintenance, and screen selection. Regular monitoring and adjustments of process parameters are essential to achieve consistent and high-quality granules for pharmaceutical manufacturing.

Extrusion Solutions

Our experience in extrusions has led us to overcome critical challenges that often arise during the process. We have successfully tackled issues such as extrudate fracturing, product degradation caused by high shear, pressure fluctuations due to screen clogging and low throughputs. With a focus on innovation and precision engineering, our team has developed ground-breaking solutions to ensure smooth and consistent
extrusion operations.

In pharmaceutical extrusion processes, extruder sieves (also known as screen packs or filters) are used to filter the extrudate and remove any
contaminants or oversized particles. However, extruder sieves can encounter certain problems that may affect the extrusion process and the quality of the final product. Some of the problems associated with extruder sieves include:

Clogging: Extruder sieves can become clogged with fine particles, agglomerates, or sticky materials, leading to reduced flow rates and pressure
build-up in the extruder.

Reduced Throughput: Clogging or fouling of extruder sieves can result in reduced extrusion throughput and productivity.

Particle Breakage: The mechanical action of the extruder sieves can cause breakage of fragile particles, affecting the product’s particle size distribution and content uniformity.

Pressure Fluctuations: Clogging or changes in the sieves’ permeability can cause pressure fluctuations in the extruder, leading to inconsistent extrudate properties.

Contamination: If the extruder sieves are not cleaned properly or replaced when necessary, they may contribute to cross-contamination between
different materials or batches.

Compatibility Issues: The choice of sieve material may not be compatible with certain formulations, leading to chemical or physical interactions that
impact product quality.

Limited Filtration Capacity: Inadequate sieves may have limited filtration capacity, allowing some contaminants or oversized particles to pass through.

Difficult Cleaning: Cleaning extruder sieves can be challenging due to their intricate design, which may result in incomplete cleaning and contamination risks.

Sieve Wear and Tear: Repeated use of extruder sieves can lead to wear and tear, affecting their filtration efficiency and requiring regular replacements.

Rheological Effects: The presence of sieves can introduce changes in the extrusion rheology, affecting the flow and behavior of the extrudate.
Temperature Sensitivity: Extruder sieves made from certain materials may be sensitive to the high temperatures generated during the extrusion process, leading to deformation or damage.

Shear Effects: The mechanical forces applied by the sieves may cause shear effects on the extrudate, affecting its structure and properties.


By addressing these problems and implementing appropriate measures, we can ensure that extruder sieves contribute to a reliable and efficient extrusion process while maintaining product quality and compliance with regulatory requirements.

Fluid Bed Drying Solutions

Fluid bed drying offers fast and uniform drying, efficient heat transfer, reduced drying times, and the ability to control drying parameters precisely. It is well-suited for heat-sensitive materials and provides good control over the final product’s particle size distribution. Our advanced fluid bed drying solutions can help you in:

Improving Drying Efficiency: Higher fluidization velocities and air temperatures generally result in faster drying rates. However, these parameters need to be optimized to prevent particle entrainment or overheating, which can adversely affect the product quality.

Controlling Critical Process Parameters: Managing inlet air temperature, airflow rate, fluidization velocity, drying time, and moisture content monitoring.

Efficient Air Distribution: Ensuring uniform air distribution within the fluid bed dryer helps prevent localized areas of high moisture concentration, reducing the chances of product sticking.

Pre-Drying or Conditioning: Pre-drying or conditioning the material before introducing it into the fluid bed dryer can help reduce its moisture content and prevent agglomeration.

Optimal Airflow Velocity: The fluidization velocity should be carefully controlled to avoid excessive turbulence that can cause particles to collide
and agglomerate. Maintaining the right fluidization velocity for the specific material being dried helps prevent agglomeration.

Preventing Air Channelling & Rat Holing: Properly designed drying conditions, the use of anti-agglomeration techniques, and appropriate
process parameters can prevent or address these issues.

Uniform Fluidisation of Variable Particle Size Material: Particle size and shape affect the fluidization behaviour, residence time, and drying rate. Smaller particles and irregular shapes can influence fluidization and drying efficiency.

Optimize the Energy Efficiency of the Process: Optimizing the airflow rate, minimizing air leakage, and implementing heat recovery systems are some
ways to improve energy efficiency.

Drying Heat-Sensitive or Moisture-Sensitive materials: For heat-sensitive materials, low drying temperatures and short drying times must be used. For
moisture-sensitive materials, proper moisture control during the drying process is critical to prevent degradation or agglomeration.

Controlling Inlet Air Humidity: Inlet air humidity affects the drying rate and can be controlled by using dehumidified air or adjusting the drying air temperature and flow rate.

Ensuring Uniform Distribution and Mixing of the material: Proper fluidization and air distribution within the fluid bed dryer ensure even contact between the drying air and the material, promoting uniform drying.

Optimising Airflow Pattern: The airflow pattern is designed to achieve uniform fluidization and drying throughout the fluid bed. Proper airflow distribution ensures efficient moisture removal and consistent product quality.

 

These answers provide insights into fluid bed drying, its applications, challenges, optimization, and safety considerations. Understanding the fluid
bed drying process is essential for pharmaceutical manufacturing, as it offers efficient drying of granules, powders, and coated particles while maintaining product quality and uniformity.

Dry Milling

  • Milling of very Hard or Soft products,
  • Processing Sticky or fibrous materials,
  • Proper Control of Particle Size Distribution,
  • Achieving ideal Size reduction in API’s, 
  • Improving Throughput,
  • Milling of Potent Drugs,
  • Dusting issues.
  • Product melting & charring while sieving,
  • Screen choking issues,
  • Improving Throughput,
  • Delumping,
  • Milling of very sticky materials,
  • Control of Extrudes,
  • Screen choking issues,

Wet Milling

Dry Milling:

  • Milling of very Hard or Soft products,
  • Processing Sticky or fibrous materials,
  • Proper Control of Particle Size Distribution,
  • Achieving ideal Size reduction in API’s, 
  • Improving Throughput,
  • Milling of Potent Drugs,
  • Dusting issues.
  • Product melting & charring while sieving,
  • Screen choking issues

Wet Milling:

  • Improving Throughput,
  • Delumping,
  • Milling of very sticky materials,
  • Control of Extrudes,
  • Screen choking issues

Dry Granulation:

  • Granulation of very Hard or Soft products,
  • Proper Control of Granule Size Distribution,
  • Control of excessive fines,
  • Reducing the cycle time,
  • Work hardening of the granule,
  • Improving Throughput,
  • Dusting issues

FBD:

  • Auto transfer of Wet granules to FBD.
  • Fluidisation issues like Racking, cacking,
  • Choking of screen,
  • Screen damage & metallic contamination,
  • Product loss in the plenum.
  • Unable to achieve proper bed temperature due to Channelling.
  • Lump formation & LOD issues,
  • Auto discharge after drying,
  • Finger Bag Choking,
  • Static Issues

Sifting & Screening:

  • Raw material screening,
  • Sieving of low bulk density products,
  • Achieving of proper size separation,
  • Controlling Pellet sizes,
  • Control of Static electricity,
  • Metallic contamination

Filtration:

    • Viscous fluids,
    • Choking issues,
    • Throughput problems.

Get One Step Ahead Of Competitors

Partnering with us means accessing cutting-edge solutions that guarantee top-notch milling performance, regulatory compliance, and enhanced overall efficiency in your pharmaceutical manufacturing processes. Experience the difference our expertise can make and take your pharmaceutical production to new heights of success. Contact us today to explore tailored solutions for your milling needs.

Book Your Consultation

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A20, SINGH IND ESTATE NO.1, RAM MANDIR ROAD, RAM MANDIR, MUMBAI, MAHARASHTRA - 400104

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+91 9766136543
+91 8828224045

Email Us

info@psizen.in