The pharmaceutical packaging market is a vital part of the global healthcare industry. Its market size is projected to reach approximately USD 342.16 billion by 2034, with a CAGR of 8.88%. This growth is driven by factors such as the rising demand for single-dose and combination packaging, increasing regulatory requirements, advancements in smart packaging technologies, as well as the need for enhanced drug safety and patient compliance. Furthermore, sustainability concerns are driving innovation in eco-friendly and recyclable packaging solutions. As a key component of the pharmaceutical supply chain, addressing evolving demands and challenges remains crucial for sustained industry growth.
The Evolving Demands of Pharmaceutical Packaging
The pharmaceutical industry has witnessed a shift toward more complex formulations. Presently, customers are increasingly adopting flexible sachets to pack a combination of granulated powder and pharma pellets, due to advancements in drug delivery, patient convenience, and packaging technology. This trend is particularly relevant for allergy treatments, which experience a surge in demand during seasonal transitions like spring and autumn.
Key factors driving this trend include:
- Granulated Powder: Provides immediate drug release for rapid absorption.
- Pharma Pellets: Typically coated for controlled, sustained, or delayed release to ensure long-lasting effects.
- Single-Dose Packaging: Patients receive an exact pre-measured dose, hence reducing dosing errors.
- Easy Consumption: Several patients, especially children and the elderly, have difficulty swallowing tablets or capsules. Sachets can be dissolved in water or directly consumed.
- Travel-Friendly: In contrast to bulky bottles or blister packs, sachets are lightweight, easy to carry, and disposable.
- Dual or Multi-Dosing Systems: Ensures accurate dosing of both components within the sachet.Allows for the simultaneous packaging of two or more active pharmaceutical ingredients (APIs) with individual release profiles.
- Four-sided seal sachets offer high moisture, light, and oxygen resistance, thus ensuring that longer shelf life depends on laminate structure.
- Sustainability: Sachets use less material than bottles or blister packs, reducing waste and costs. The rise of biodegradable and recyclable sachets aligns with industry sustainability goals.
- Stick Pack Format: Offers the varied benefits in the pharmaceutical industry with a more compact presentation, which can reduce around 25% of the packaging material required. Also able to be used for liquid formulations such as pharmaceutical syrups.
The Role and Challenges of Active Ingredients
Active ingredients hold a crucial role in the efficacy of pharmaceutical products. Their accurate weightage is paramount, as even minor deviations can significantly impact therapeutic outcomes. Handling low volumes of active ingredients, such as 10mg pellets, requires precision and consistency. The fusion of powder and pellets within the same sachet introduces another layer of complexity, as this demands meticulous control of the handling and packaging processes.
Key Flexible Packaging Challenges in the Pharmaceutical Segment
1. Accurate Dosage: The need for high accuracy in both the formulation and packaging processes is non-negotiable. This can be the result of particle size, flow properties, and product density Any deviation can lead to regulatory non-compliance and potential health risks.
2. Fusion of Powder and Pellets: Combining powder and pellets within the same sachet requires advanced technology and precise control. This process must ensure that the active and inactive ingredients are handled and packed separately. The ingredients need to remain stable throughout the lifecycle of the product, which is accomplished by selecting a proper laminate structure.
3. Material Nature: Some pharmaceutical powders and coated pellets are hygroscopic and degrade upon exposure to moisture. This leads to a shorter shelf life.
4. Heat Protection: Sachet packaging must protect both powder and pellets from environmental factors while ensuring that heat sealing does not damage drug integrity. Poor sealing can lead to leakage, contamination, or compromised drug stability.
5. Compliance: The guarantee of the correct dose, content uniformity, and stability testing as per FDA, EMA, and GMP guidelines. Product recalls and regulatory penalties can be the result of failure to comply.
6. Low Volume and High Productivity: Ensuring the accurate measurement and processing of low volumes such as 10mg, while maintaining high productivity, is a significant challenge. Precision is critical for maintaining the efficacy and safety of the final product. Efficient packaging solutions are necessary in order to manage complex formulations without compromising speed or quality.
7. Retrofitting: Standard sachet filling machines are designed to perform single-product dosing. Modifying them for dual or multi-dosing requires advanced automation, hence increasing capital investment and machine downtime for configuration.
While packaging the fusion of granulated powder and pellets in sachets presents challenges such as weight accuracy, stability, and production capacities, advancements in packaging machinery, material science, and regulatory compliance are enabling the industry to overcome these hurdles. Investing in precision dosing systems, high-barrier materials, and high-speed packaging machines will be crucial for successful implementation.
Mespack HFFS: Precision Sachet Packaging for Powders and Pellets
Mespack’s Horizontal Form-Fill-Seal (HFFS) technology is well-equipped to manage the complexities of packing a fusion of granulated powder and pharma pellets into four-sided seal sachets. The following explains the manner in which Mespack’s HFFS solutions address the aforementioned key challenges:
- A multi-dosing system integrates both auger fillers (for powder) and micro feelers (for pellets) within the same machine.
- Servo-driven dosing ensures consistent dose control, thus reducing variability in regard to sachet content.
- Precise dosing for granulated powder, as low as 100mg, is manageable with the use of special auger feeler designs
- Precise dosing for pellet, as low as 10mg, is manageable with the use of a micro feeler.
- Equipped with real-time weighing feedback loops to eliminate over- or under-dosing issues.*
- A four-sided seal that ensures hermetic protection, which avoids leakage and contamination.
- Ability to manage high-barrier flexible laminates (PET/Alu/PE) for sachets in order to protect against humidity and oxygen.
- Controlled humidity environment in the filling chamber in order to prevent powder clumping.
- A nitrogen flushing system that removes residual oxygen, thus enhancing the shelf life of moisture-sensitive drugs.
- Custom-configurable HFFS platforms which support dual and multi-dosing systems in a single cycle.
- Machines that provide tool-free adjustments, hence enabling quick changeovers between different formulations.
- Heat-sensitive formulations due to the use of cooling technology after the heat sealing process of sachets.
- Precise temperature-controlled sealing bars prevent drug degradation.*
- Automated in-line quality control with a rejection system for empty sachets.
- Equipped with a no product no fill function.
- A simplex machine can manage 50-60 sachets per minute, and has a duplex option of 100-120 sachets per minutes, as well as a quadruplex option (four up) to complete 280-300 sachets per minutes.
- cGMP-compliant machine design (easy cleaning and no contamination dead zones
- Supports 21 CFR Part 11 compliance (electronic data logging and batch traceability).
Mespack’s HFFS sachet packaging solutions provide an optimized, high-precision, and compliant method for packing granulated powder and pharma pellets together in four-sided seal sachets. With multi-dosing capabilities to achieve better accuracies, advanced sealing technologies, high speed solutions, and regulatory compliance, Mespack machines have effectively vanquished the common challenges confronting pharma sachet packaging.
(*) When the configuration of the machine includes the specific items to carry out this function.
