• Dosage forms

  •  · Granules, Fine granules, and Powder
  •  · Plain tablets
  •  · Film-coated tablets
  •  · Sugar-coated tablets
  •  · Multi-layer tablets
  •  · Orally disintegrating tablets
  •  · Dry coated tablets
  •  · Hard capsules
  •  · Soft capsules (manufacture of solutions for internal use)

• Manufacturing features of solid dosage forms

  •  · Explosion proof facilities
  •  · Coating of fine particles
  •  · External lubrication system of a tablet press
  •  · Capsule filling unit
  •  · Small scale to large scale manufacturing
  •  · Crushing of bulk drugs
  •  · OSDrC technology (dry-coated tableting)

Inspection and Packaging Injectables

We inspect and package filled vials, syringes, and ampoules manufactured overseas. Our large refrigerated warehouse enables us to handle clinical samples and pharmaceutical products that require refrigeration.

Ensuring your product with no defects is essential to customers’ success in any markets. Bushu Pharma has strengthened its Inspection and analysis. We have the know-how, skillful inspectors, analysts and equipment to expertly conduct inspection and analysis of your product – checking for visual defects of both the product and packaging.

This function is a core part of our Bushu Pharma for injectables. Three key areas that are focused on to ensure all products meet quality requirements for the Japan market are:

• Inspection of the cosmetic quality of bulk drug products
• Inspection of the cosmetic quality of packaged products
• Analysis for the presence of foreign materials

In order to meet market expectations for quality control in each of these areas, we employ the general following practices:

Injectable products:

Products in vials and syringes are rigorously inspected following the filling process to detect and remove any microparticles in solution such as glass and fibers, to meet the specified regulatory requirements for distribution within Japanese markets and overseas.

Finished products:

The cosmetic quality of finished drug products can be inspected by well-trained operators who remove defects – such as dents or scratched carton boxes.

Foreign materials:

Once foreign particulate matter is detected, we perform analyses using a range of instruments to identify root cause(s) of entry and propose improvements of the manufacturing process.

Factory personnel responsible for the inspections listed above are skill-certified personnel. It is obligatory for them to undergo annual skill testing for certification renewal.

To support quality control in terms of foreign materials, we make quick response to market complaint and foreign matters found in manufacturing process. Both non-destructive and destructive analysis are available. Our knowledge and experiences of manufacturing is the practical approach the foreign materials from the results of analysis. As our representative scheme, we make Microscopic observation, Element analysis by X-ray Microscope, Identification by Raman, and Identification by FT-IR.

Our manufacturing environment is based on hazard assessment, exposure assessment, and implementing strict residue management.

In addition, we monitor the environment and verify the containment by measuring the exposure to workers. We target APIs with an OEL (Occupational Exposure Limit) of 1μg/m³ or less. The production scale is mainly 5 to 15 kg, and the dosage forms are granules, uncoated tablets, and coated tablets.

Based on the safety information, we evaluate the APIs and decide whether we can handle them or not, taking into account the dosage form and the manufacturing process.

Main Equipment for High Potency Product Formulation

High speed agitation granulator / Fluidized bed granulator / Particle sizing equipment / Tableting machine / Packing machine

High Potency Tablet Dosage Form

• OEL

  0.15-1μg/m³(principle)

• Scale

  5kg-15kg

• Dosage
  form

  Granule/ Plain tablets/
  Coasted tablets

• Production Equipment

  • Closed system
  • Glove box
  • Flexible enclosure
  • Isolation flap
  • Local exhaust ventilation system

• Production Area

  • All fresh air-conditioning system
  • Monitoring system
  • Mist shower
  • Independent dedicated air-conditioning system
  • Dedicated purified water generation system

• Rigorous Operating Policy

  • Cleaning validation
  • Dedicated equipment and instruments
  • Entire cleaning procedure for production room/auxiliary chamber
  • Prevention of cross-contamination
  • Monitoring of exposure/leakage
  • Disposal of cleaning tools and clothes

• Solid Form

  Drug Products

  •  · Granules
  •  · Tablets
  •  · Capsules
  •  · Dry Syrup

  Primary / Secondary Packaging

  •  · Blister
  •  · Stick Package
  •  · Bottle

• Injectable Form

  Dosage forms

  •  · Vials (liquid and lyophilized products)
  •  · Pre-filled syringe

  Inspection Assembling

  •  · Vials
  •  · Pre-filled syringe
  •  · Auto Injector

  Secondary Packaging

  •  · Vials
  •  · Pre-filled syringe
  •  · Auto Injector

• Medical Device

  Secondary Packaging

  •  · Inspection of medical devices
  •  · Packaging of drug-device combination products

  Regenerative Medicine

  Secondary Packaging

PTP and bottle packaging

•  · We are equipped with filling machines suitable for packaging of two-sided aluminum medical blister packs.

Packaging Line Highlights

•  · Automatic line
•  · In-line visual inspection cameras
•  · Packaging under strict controlled conditions at low temperature (2-8°C)

Packaging and Artwork

From the sourcing of suitable materials to the design of packaging that can preserve the shelf life of your product, Bushu Pharma will consult closely with you to help bring your product to market.

It is possible for us to print on PTP packages, bottle containers, anti-counterfeiting packages, GS1 Bar Code, etc. We offer a variety of technical solutions, for example package design, such as minimizing the size of individual boxes, and support for artwork designing.

Vendor Management

Bushu Pharma manages packaging and distribution suppliers in the quality agreement process, quality audits, packaging material specification, and incoming tests.

Artwork Management

Bushu Pharma can expertly handle packaging labeling (artwork) development and changes through the following steps:

• Draft artwork design
• Finalize artwork (approval)
• Procure packaging materials after artwork approval
• Acceptance test of packaging materials

Bushu Pharma has accommodated an increasing demand for clinical samples each year. We cover contracts from shallow, small-scale and early phases to large-scale and final phases.

Bushu Pharma has a well trained Clinical Trials Team in our packaging department, providing the following services:

•  · Package engineering
•  · Package material management
•  · QC test
•  · GMP release
•  · Product delivery

They are well trained for any Clinical Trials package and are able to provide the service with just a short lead time.

Under our GMP system based on extensive experience with inspections in Japan and overseas, we are able to conduct tests on a wide range of pharmaceutical products from low-molecular weight drugs to high-molecular weight drugs. In particular, we have the technologies and facilities to handle the testing of bio-pharmaceuticals such as antibody drugs, and we are able to provide testing using cultured cells (cell-based assay) that require sophisticated techniques.

We also have a laboratory for high potency substances and technologies to analyze foreign matter and are able to meet the varied analytical needs of our customers with regards to pharmaceutical products.

For DDC (drug & device combination), Bushu Pharma manages the following operations:

•  · Inspection of medical devices
•  · Packaging of drug-device combination products

Our experts are able to respond to the needs associated with veterinary medicine. Industrial transfers can be made smoothly through the use of equipment which is similar to their existing manufacturing equipment. Our GMP laboratory can also carry out stability studies.

We accept contracts for transfer of the manufacture of pharmaceutical products and clinical samples of solid dosages and injectables as well as related quality control tasks.

Our expertise in technical transfers has been developed over 20 years through QC Technical Transfer of Analytical Methods under USP, EP, JP and ICH.