Content uniformity and dosage weight variability can be due to segregation issues. The pharmaceutical industry is driven by two key strategies, namely reducing costs or incorporating new technologies (e.g., Process Analytical Technology – PAT – or new drug delivery systems).

Reducing costs may require use of new raw material suppliers, which could result in unplanned process variability or unanticipated process changes.  Perhaps you are on the other side of this relationship, whereby you are unsure if your process changes will affect your customer.  On the other hand, newer materials and manufacturing techniques demand a better understanding of the process as a whole.  This may include implementing various programs such as six sigma, PAT, quality-by-design (QBD), or specific FDA guidance documents, with the goal of improved quality and reduced time-to-market.  Novel techniques (e.g., continuous blending) in the pharmaceutical industry can pose increased risk and effort to implement.

Pharmaceutical Industry Services

Our engineers are knowledgeable with cGMP practices, FDA regulatory requirements, operations involving milling, compaction, agglomeration, drying, and the latest pharmaceutical powder handling innovations.

Common Pharmaceuticals Industry Challenges

Jenike & Johanson can provide you with knowledge of how pharmaceutical powders will behave from raw material dispensing, blending, storage, transfer, and through the creation of the final dose.  This knowledge can be used to avoid and solve problems related to poor flow, as well as segregation, blend and content uniformity.  We are also active participants in the research conducted by the ISPE Blend and Content Uniformity Initiative. Variability in pharmaceutical solid dosage form (e.g., tablet, capsule, or chewable) mass can be directly attributable to non-uniform powder flow and insufficient blending.  Tableting problems such as capping, delamination, or erratic hardness are often due to air and powder interaction at compaction.

Common Materials Handled

Below, please find a shortened list of the bulk materials we have successfully handled in the Pharmaceuticals industry to date. Please note the below list is just a small sampling of the materials we’ve handled for clients in the Pharmaceuticals industry.

  • Active pharmaceutical ingredients (APIs)
  • Antibiotics
  • Opiates, analgesics
  • Excipients
  • Hormones
  • Therapeutics
  • Placebos
  • Contraceptives
  • Vitamins, nutraceuticals
  • Analgesics
  • ACE Inhibitors
  • Antibiotics / Penicillin
  • Anticoagulants
  • Anticonvulsants
  • Anti-depressants
  • Antidiabetics
  • Antihistamines
  • Anti-impotence
  • Channel Blockers
  • Cholinergics
  • Cough / Cold / Allergy
  • Hormones
  • Narcotics
  • Placebos
  • Protease Inhibitors
  • Reductase Inhibitors
  • Vitamins
  • Powder Types
    • Excipients
    • Fine Granulations
    • Low Dose, High Potency Direct Compression Blends
    • Oral Suspensions
    • Pure Active
    • Wet and Dry Granulations
    • Wide Particle Size Distribution Blends

Pharmaceuticals Industry Clients

Below, please find a sampling of clients who we have successfully provided bulk material engineering services for in the pharmaceutical industry.

  • Pfizer
  • Merck
  • Eli Lilly
  • Abbott Laboratories
  • Johnson & Johnson
  • Bristol Myers Squibb
  • Novartis
  • Janssen
  • Warner Chilcott
  • Abbott Laboratories
  • Agouron
  • American Pharmaceutical Partners
  • Amgen
  • Aventis
  • Bayer
  • Bristol Myers Squibb
  • Ciba Geigy
  • Delsys Pharmaceutical
  • Eli Lilly
  • Genzyme
  • Inhale
  • Janssen Pharmaceutical
  • Johnson & Johnson
  • JRH Biosciences
  • Lederle Labs
  • Merck
  • Merck, Sharp & Dohme
  • Novartis
  • Ortho-McNeil Pharmaceutical
  • Pfizer
  • Pharmacia
  • Procter & Gamble
  • Purepac Pharmaceuticals
  • Rhone-Poulenc
  • Roche
  • SmithKline Beecham
  • Syntex
  • Warner Lambert
  • Whitehall Labs
  • Wyeth Ayerst
  • Zeneca