Bactolac Pharmaceutical’s new manufacturing facility in New York, US, is located alongside its existing facility in Hauppauge. Launched in August 2009, the new facility has doubled Bactolac’s total facility space and daily production capacity.
The new facility is a 60,000ft² building certified with good manufacturing practices (GMP). It has doubled the total facility size to 120,000ft².
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For over 15 years Bactolac has developed formulas for a host of conditions including weight loss, stress relief, relaxation, sports nutrition, immune improvement, life extension, brain function, energy products, antioxidants and several herbal treatments.
The new facility has strengthened Bactolac’s position in the nutritional supplements contract manufacturing industry.
Bactolac’s facility
The combined cGMP-compliant facility is equipped with HVAC technology systems that monitor temperature and air quality. It accommodates micro and analytical laboratories as well as production space.
The microlaboratories maintain the purity of products and ensure that the products are free from contaminants. The analytical laboratories develop methods and validate and test products to ensure strict label adherence.
Lab equipment at the facility includes a gas chromatograph, high pressure liquid chromatography, UV spectrophotometers, infrared spectrophotometers, inductive coupled plasma spectrophotometers (ICP-OES), ICH stability chambers, a disintegrator, tablet hardness tester, incubators, autoclaves, bio-safety hoods and a range of instruments to assist in monograph testing.
The dust-contained facility is designed to facilitate easy changeover and quick processing times. It is fully equipped with multiple capabilities such as superior material handling, film and sugar coating and advanced manufacturing skills. There is also an extensive warehousing facility.
Additional equipment within the facility include ergonomic load lifters, high efficiency rotary compression machines, fully automated high speed encapsulation machines, high performance screening and milling machines, and FDA-certified large capacity V and ribbon blenders. It also has automated packaging lines, gravity feeding distribution silos, automatic blister packaging and a large shrink wrap.
Process technology
The facility develops products based on the nutraceutical formula of each client. Should the client have a concept but not a formula, Bactolac scientists can custom-design a specialised formula that matches the concept.
Once the desired supplement formula is developed and approved, the facility weighs, tests and verifies the product materials in precise quantities.
The material is then sent to a designated blender where it is sequentially added. The blender is then rotated for a specified mixing period.
To ensure that each product is produced in compliance with the standards, formulation analysis is carried out by batch. The vitamin or nutraceutical blend is then prepared in the required dosage form and packaged.
Production
The Bactolac facility produces dietary supplements in powdered, encapsulated and solid dosage forms including capsules and tablets. The facility uses an inventory of more than 5,000 raw ingredients. It produces coloured, imprinted, NP, pearl, soft gels and vegetarian capsules; as well as bi-layer, chewable, colour-coated, effervescent, enteric-coated, film-coated, imprinted, pharmaceutical glaze, sublingual-coated, sugar-coated and time-release tablets.
The facility develops powders as blends that are used in meal replacement bars, electrolyte drink mix, meal replacement powder combinations, multi-vitamin and mineral blends, green food powders, red berry powder and protein powders.
All products manufactured at the facility can be custom-packaged in blisters, bottles, boxes, coloured caps, CRC caps, flip-tops, pouches, shrink wrap, stick packs and jars with induction seal, inserts and labelling.
Bactolac capacity
The facility compresses 15 million tablets and coats six million tablets every day. Each day the facility blends 25,000kg of powder and encapsulates six million capsules.
The bottling, powder filling and blister packing capacity of the facility is 100,000 units, 35,000 units and 1,000,000 units per day.
