Sterile Semi-Solid Manufacturing
Halo’s facility in Whippany, NJ has been manufacturing sterile semi-solids for over 30 years.
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.
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.