Semi-Solid Dosage

Semi-Solid Dosage2018-07-13T00:11:28+00:00
Semi-Solid Dosage

Halo's facility in Whippany, NJ has been manufacturing sterile and non-sterile semi-solids for over 30 years.

Sterile Semi-Solid Manufacturing

Through the use of stringent controls of aseptic conditions as well as highly trained production operators, Halo has established itself as a leading global provider of aseptic topical products. Halo has an excellent track record of sterility assurance and USFDA compliance for the suite including the manufacturing of ointments, creams and gels for both biologics and small molecules.

  • Tube sterilization through gamma irradiation and in-coming tube logistics are managed by Halo personnel using validated methods, qualified protocols and vendors
  • All compounding is carried out in a class C area
  • Aseptic 0.22 um filtration or in-situ steam sterilization are offered
  • Production can utilize  glove ports for the transfer of  sterile API via an aseptic transfer vessel
  • Components are filled under Class A conditions
  • Labeling and cartoning services are also offered

Halo performs aseptic media fills and operator qualifications on a frequent basis. We produce almost 1MM tubes/year and can produce up to 4X that volume if need be. Halo offers a full range of microbiology and analytical QC services in support of the production of sterile semi solids.

Suite Capabilities

Halo’s sterile semi-solid suite is fitted with a Krieger 600 MMD batch processor that can handle batch sizes ranging from 200 Kg – 450 Kg.  In addition, we have an IWKA TF 20 Robotic Tube Filler to minimize human contact in the tube filling process.  The suite is capable of filling tubes ranging from 3.5 grams up to 100 grams of ointments, creams or gels.  The suite can manufacture bulk up to 200,000 Kg annually.

Non-Sterile Semi-Solid Manufacturing

Through the use of stringent controls as well as highly trained production operators, Halo Pharma has established itself as a leading global provider of topical products. Halo has an excellent track record of USFDA and Health Canada compliance including the manufacturing of ointments, creams and gels for all types of topical compounds.

  • Pilot, clinical trial material and commercial-scale manufacturing
  • Segregated manufacturing suites
  • Semi-solid cGMP batch sizes from 25 kg to 1000 kg
  • Vacuum Deaeration
  • Labeling and cartoning services are also offered

We can produce up to 325,000 Kg of bulk topicals. Halo offers a full range of microbiology and analytical QC services in support of the production of non-sterile semi-solids.

Suite Capabilities

Halo’s non sterile semi-solid suites are fitted with a development and pilot scale Ekato Unimix SRC-150 that can handle batch sizes ranging from 25 Kg – 150 Kg.  The Ekato is equipped with state of the art vacuum de-aeration and can handle viscous polymers.  In addition, our production scale equipment can handle batch sizes up to 1,000 liters.  Our tube filling equipment includes a Romaco Unipac U 20100 automatic tube filler capable of filling laminate, plastic, aluminum tubes at high speed.   Our tube filler is capable of filling tubes ranging from 2 grams up to 240 grams of ointments, creams or gels.

Suppositories

Halo has development and production scale suppository filling machines at our Whippany and Mirabel facilities. Between both of our sites we can produce over 100 million units annually.