News - ODF Scale-Up: From Laboratory to Commercial Production

Formulations that behave well in the laboratory often behave differently on production equipment. Coating consistency, drying rate, solvent evaporation and lamination quality all change with scale, and a film that dries evenly in a small batch can curl, block or vary in drug content when run continuously. Scale-up is therefore less a question of machine size than of whether the same process principles are reproduced at larger scale.

Quick Answer

One stop pharmaceutical engineering for ODF production means a single supplier is responsible for design, equipment supply, installation, commissioning, validation support and training, instead of the buyer coordinating several contractors. Aligned Machinery supplies ODF lines covering emulsification and film casting through drying, slitting, packaging and cartoning, and provides formula testing so that process parameters can be established on pilot equipment before a full-scale line is built.

Why ODF Scale-Up Depends on Process-Specific Equipment

Oral thin film performance depends on parameters that are interdependent: film thickness, mechanical flexibility, drug release profile and residual solvent level. A change in drying temperature affects residual solvent, which affects mechanical properties, which affects how the film behaves during slitting and packaging. Because of this coupling, equipment built for tablets or capsules does not transfer directly to film production.

Aligned Machinery’s ODF equipment is designed around these steps. The company was founded in 2004, holds more than 68 independently developed patents, and supplies equipment to more than 550 companies in over 100 countries. The company has supplied oral dissolving film equipment since 2018, and CE documentation is available for the products supplied.

Stages of an ODF Production Line

1. Emulsification and Mixing

The formulation is prepared before casting. Consistent mixing and deaeration at this stage reduce variability downstream.

2. Film Casting and Drying

The ZM-340-4M Automatic Oral Thin Film Making Machine coats the liquid material onto a base roll and dries it in a continuous unwinding, coating, drying and rewinding sequence. Published parameters: maximum casting width 360 mm, film roll width 400 mm, running speed 0.1–1.5 m/min depending on formulation and process, temperature control 30–80 °C ±2 °C, edge of reeling within ±3.0 mm.

The drying oven is divided into independently controlled partitions with separate automatic control of temperature, humidity and concentration, so the drying profile can be set zone by zone. The drying section can also be lengthened to suit the required output. Parts in contact with the material are made of stainless steel and non-toxic materials meeting GMP requirements, and the lower transmission area and upper operation area are On Aligned Machinery ODF equipment, parts in contact with the product are made of 316L stainless steel, while other parts are generally 304L stainless steel and can be supplied in 316L where the project requires it.sealed and isolated by stainless steel plates to limit cross-contamination.

3. Slitting, Conditioning and Printing

The KFG-380 peels the film from the mylar carrier, dries it for uniformity, slits it to width and rewinds it for packaging. It runs at 0.002–5 m/min with a finished film width of 110–190 mm (standard 380 mm), and can be fitted with laser printing. One slitting unit can support three packaging machines, which is worth accounting for when balancing line output.

4. Packaging and Cartoning

The KFM-300H cuts, integrates, compounds and heat seals the film into pouches at up to 1,200 packs per minute, with heat sealing at 10–35 cycles per minute and 36 packs per cycle. Visual inspection for edge rolling, missing parts and damage is standard, as is double-sided registration; finished pouches move on a vacuum adsorption conveyor with a pneumatic reject device. Pouches can then be cartoned on the KXH-130.

Three Scale-Up Barriers and How They Are Addressed

Content Uniformity

ODF strips are thin and often carry a low dose, so the active ingredient has to be distributed evenly across the full width of the film. Uniformity depends on coating consistency and on drying that removes solvent evenly rather than quickly at the surface. Aligned Machinery specifies thickness consistency within ±2 µm for its ODF lines, and the independently controlled drying partitions allow the profile to be adjusted zone by zone.

Mechanical Properties

Films need to be flexible enough to handle and package without cracking, while remaining strong enough for the patient to remove and use. The drying profile drives this balance: excessive heat can make films brittle, insufficient drying leaves them tacky and prone to blocking. Independent control of each drying partition allows the profile to be set for a specific formulation.

Technology Transfer

When development and production use different equipment, parameters established in the laboratory often need to be reworked. Aligned Machinery addresses this through formula testing on pilot-scale equipment: since 2019 the company has run 1,369 formula tests (82,140 minutes) and 2,312 equipment commissioning runs (138,720 minutes), with more than 200 enterprises taking part. The ZM-120 lab-type oral dissolving film making machine is available for early-stage work.

How a One Stop Project Is Structured

Aligned Machinery divides project support into three phases:

Before: tailored process design, feasibility analysis and technical recommendations.
During: trial runs, performance verification and process parameter optimization for stable operation.
After: operator training and SOP guidance, plus remote and on-site technical support when needed.

The wider turnkey workflow runs through engineering (plant layout, cleanroom design, URS review), procurement, construction (FAT and SAT verification, on-site installation and assembly), validation (IQ/OQ/PQ documentation and operator training) and ongoing support.

FAQ

What is included in a turnkey ODF production line?

A turnkey line covers the process from emulsification and film casting through drying, slitting, packaging and cartoning, together with the supporting project stages: plant layout and URS review, equipment manufacturing and integration, FAT and SAT verification, on-site installation and commissioning, IQ/OQ/PQ documentation support and operator training.

Can ODF equipment be added to an existing facility?

Yes. Individual machines, such as a film making machine, a slitting and drying machine or a packaging machine, can be supplied for installation in an existing facility with cleanroom and utility systems already in place. In that case the customer takes on more of the integration and technology transfer work than with a full turnkey line.

How are formulation-specific requirements handled?

Aligned Machinery runs feasibility studies and formula testing on pilot-scale equipment that follows the same coating, drying and cutting principles as full-scale lines. These trials set casting parameters, drying profiles and cutting methods for the specific formulation, producing process settings that can be transferred to production equipment.

What support is provided after installation?

Support includes operator training and SOP guidance, remote assistance, on-site technical support when required, technical troubleshooting and warranty service covering wear part replacement and repair during the warranty period.

Can one line produce different film sizes and formats?

Yes. Lines can be configured for multiple film sizes and formats, with adjustable slitting widths, programmable drying profiles and changeable tooling. The KFG-380 produces finished film widths of 110-190 mm, and one slitting unit can feed three packaging machines, which helps when running several products on shared equipment.

Conclusion

Scaling ODF production is mainly a matter of reproducing the same coating and drying conditions at a larger width and higher throughput. Equipment designed for film – with independently controlled drying zones, continuous casting and rewinding, and in-line inspection at the packaging step – gives fewer variables to re-tune during commissioning than adapted solid-dose machinery.

To discuss ODF scale-up or arrange formula testing, contact Aligned Machinery.