Non-Aseptic Fill Finish & Lyophilization

We can formulate aqueous solutions in addition to viscous slurries. We have a variety of formulation vessels and mixing technologies to formulate your raw materials prior to filling and lyophilization, and if temperature control is required, we can maintain the temperature of your product throughout the formulation and filling process.

We have three automated non-aseptic fill-finish lines able to fill vials and syringes in quantities up to 15,000 units per batch. We utilize peristaltic pump technology to fill aqueous solutions and positive displacement pumps for viscous slurries including chitosan or cellulose materials. Our GMP non-aseptic freeze-drying capacity ranges from 30 ft² to 260 ft² across ten lyophilizers.

We have expertise in formulating and lyophilizing collagen and biomaterials for a variety of indications including:

• Spinal
• Dental
• Orthopedic
• Hemostasis
• Wound care
• Dural repair
• Tendon repair
• Nerve repair

We utilize both disposable or dedicated stainless steel trays and molds for lyophilizing collagen or biomaterial-based materials to maximize the yield of each batch.

We work with our clients to develop a variety of thermal and chemical crosslinking processes to strengthen the collagen devices we manufacture.

We can mill your lyophilized material as an intermediate step of the manufacturing process to facilitate further onward processing.

Our packaging services include labeling and kitting, heat sealing pouches and custom blister trays with Tyvek® lids, final kitting with product specific cartons, labels, gamma indicators and more.