Many manufacturers know that in today's economic climate it is often wiser to turn to specialists for product fulfillment than to attempt an in-house operation. The term for this is "outsourcing". In HANFORD's modern era, much of its antibiotic production has borne the labels of younger but more famous names in the pharmaceutical industry.

HANFORD has long served as an outsourcing 'silent partner' in providing manufacturing services in the production of hospital-targeted pharmaceuticals for clients like Abbott Laboratories, American Home Products, Bristol-Myers Squibb, Hoechst Marion Roussel, Merck, Pfizer, Schering-Plough, SmithKline Beecham, Pharmacia and AstraZeneca.

Today, HANFORD remains the United States' largest producer of natural penicillins. And, HANFORD operates one of America's most advanced and successful cephalosporin plants.

HANFORD Pharmaceuticals has been in business since 1846. The company has sustained itself and grown to the present day because of one simple fact: HANFORD is the best at what it does. And, in so becoming the 'best', HANFORD has made the manufacture of pharmaceuticals into an art form. There are twelve components to HANFORD's technology and what follows is a detailed explanation of each phase in 'The Art of Pharmaceutical Manufacturing'.

The Art of Component Selection —

For years, HANFORD manufacturing specifications have been among the most stringent in the pharmaceutical industry.

Reflecting a continuing commitment to exceed all government standards, HANFORD has become one of the most demanding customers of product components.

Here, a quality control technician inspects vials sourced from the glass factories of France — where centuries of experience in shipping fine wines around the world now helps reduce breakage of prescription drugs.

HANFORD glass specialists have surveyed suppliers throughout Europe and America to select the best source for every bottle size and configuration.

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The Art of Stopper Washing —

At this station, a technician prepares a HANFORD stopper washer to begin its automated cycle. (Prewashed stoppers are also sometimes used, but only when vendor washing meets HANFORD's strict standards.)

Conventional tub tumblers bulk-wash vial stoppers. But tests demonstrate that bulk-washing can create as much particulate contamination as it removes.

HANFORD's unique serpentine-tracked machines function like a miniature car wash — stoppers are moved through the process and are counted while being individually cleaned.

HANFORD specifications also demand that only Water For Injection (WFI) be used throughout for any wash, including pre-rinses, of any equipment in contact with product. (Government regulations mandate that WFI be used for just final rinses of stoppers.)

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The Art of Vial Sterilization —

The graphic display panel of one of the world's most advanced vial sterilizers glows with information as a technician, background, inspects the tunnel. HANFORD sterilizers feature Zone-Isolated Laminar Air Flow throughout the cooling process.

As in conventional sterilizers, infrared radiation heats each vial to a temperature of 350° C.

Unlike conventional equipment, discrete laminar air flow 'cages' within the tunnel protect the preheating, sterilization and cooling zones from outside contamination, as well as interzonal air exchange.

An added benefit is a reduction of temperature fluctuations, often associated with glass breakage interruptions.

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The Art of Clean Room Design —

HANFORD was the first American manufacturer to collaborate on an innovatively engineered total-environment laminar airflow system — the HANFORD AirShower.™

Here, a technician checks one of several control panels monitoring air pressure throughout the cocoon-type clean rooms.

Featuring full-overhead filtration and full-perimeter air returns, the HANFORD AirShower surpasses all government regulations for Class 100 clean rooms. The advanced AirShower System washes vial filling areas with nine air exchanges per minute!

And, unlike other production protocols, all incoming non-sterile raw materials are sampled under Class 100 HEPA filtered air to minimize contamination.

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The Art of Vial Filling —

In HANFORD's AirShower® environment, a technician views a video monitor displaying data generated by one of HANFORD's Zanasi Sterile Powder fillers.

Rated at an unprecedented 300 vials-per-minute with continuous nondestructive sample weight-checking, this station is one of two already on-line at HANFORD.

The performance of each of 24 high-velocity fill ports is consecutively audited, instantly comparing fill-weights against empty-vial weight checks.

A constantly updated trend analysis of these data is graphically illustrated on screen, as well as recorded on a print-out.

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The Art of Blending —

Most production facilities depend exclusively on 'slow mix' paddle blenders. But some mechanically mixed compounds for injection are notoriously difficult to store. For example, penicillins tend to separate, settling into the bottom of the bottle.

HANFORD's proprietary MicroSuspension® process uses high-speed vortex mixers coupled to vacuum deaerators. HANFORD antibiotics in suspension are, with just a quick shake, instantly ready for injection — no matter how long they've been stored. (Of course, expiration dating still applies.)

Here, a technician confers with a supervisor on the other side of the sterile suite's glass port as vortex mixers atop the vats, background, blend HANFORD's trademarked MicroSuspension.

The MicroSuspension process reflects HANFORD's commitment to practical product innovation.

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The Art of Quality Control —

HANFORD's experienced visual inspectors study each vial as it moves through multiple Siedenader Stations. The slightest product imperfections are revealed by the booth's intense illumination.

Other manufacturers follow current trends to out-source support functions. Even vital quality assurance steps, whose results must be instantly available, are increasingly left to off-site vendors.

But HANFORD created its own on-site QualityLabs™ facility modeled after the best laboratories found among our PhRMA-company clients. There, HANFORD scientists conform to internal standards exceeding those set by federal regulatory inspectors.

Tools and technology include sensitive High Pressure Liquid Chromatography Stations with photodiode array detectors, as well as Oasis Isolator tests suites, in which every lot of HANFORD product is assayed for sterility.

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The Art of Labeling Vials —

Pharmaceutical production is often burdened by sudden demands for last-minute label changes or corrections. Nevertheless, most packaging plants rely on off-site subcontractors for labels, potentially causing manufacturing delays.

But just an elevator ride from HANFORD's packaging line is a fully-equipped printing center featuring a multi-color flexographic press. The latest high-magnification video monitoring technology permits continuous and exacting review of label print quality without interruption.

And, almost alone among private-label packagers, HANFORD lot numbers and expiration dates are printed as part of the high-resolution label image — providing unmatched clarity and resolution.

(Conventionally printed labels are lot/date stamped as they're applied. Blurry or smudged impressions are the most common cause of product rejection.)

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The Art of Stability Testing —

A shift in bulk suppliers, or, a manufacturing site change, or, even an alteration of package materials – any deviation from previously approved production is subject to exhaustive stability testing.

HANFORD's specially designed Stability Chambers are continuously electronically monitored for 'normal storage standards' of temperature and humidity. They also feature accelerated environments to rapidly collect stability data.

The result is that HANFORD's on-site R&D engineers, chemists and microbiologists routinely bring clients' products to market faster.

In fact, HANFORD's on-site Validation and Calibration Group ensures that HANFORD's own processes are always operating within the tight specifications established. No other contract manufacturer invests in so many staff professionals ready to consult whenever needed.

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The Art of Training Professionals —

Ultimately, investment in the latest production technology is little assurance that a physical plant and its fixtures can, in fact, produce sterile injectables. This most demanding of pharmaceutical specialties depends not only on hardware but also on highly trained and experienced technicians.

HANFORD Pharmaceuticals is committed to equipping its production team with unprecedented credentials

Unique among organizations of its size, HANFORD's Core Team Certification Program mandates comprehensive classroom training for all employees whose assignments place them near any sterile core in any HANFORD plant. Every year following initial certification, each participant is then retrained and recertified. (That's the only way they keep their jobs!)

Since 1996, dozens of HANFORD technicians have been tested and have successfully demonstrated their expertise in sterility technique and production!

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The Art of Power Reliability —

All production progress – despite the efforts of the best trained professionals and state-of-the-art equipment – can come to an abrupt halt if there is a lengthy disruption in electrical power.

HANFORD Pharmaceuticals is a forward-looking company that prepares for manufacturing 'worst case scenarios' and the loss of power is as bad as it can get. HANFORD has taken steps to ensure there is no catastrophic power loss to its manufacturing processes.

Working with area power supplier, Niagara Mohawk, HANFORD has created an industrial-level UPS (uninterruptable power supply) that ensures continual, stable voltage at all times. This is a modification of the same UPS systems used in hospitals and military installations.

Also, the range of electrical power HANFORD has available is very impressive:

• Plant Number One has access to 3,000 amps (480/277 3-phase)
• Plant Number Two: 4,000 amps (480/277 3-phase)
• Plant Number Three: 3,000 amps (480/277 3-phase).

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The Art of Technology Services

Twenty-first Century manufacturing mandates that an entire process be inter-connected via means of networking and data exchange. In this respect, pharmaceutical manufacturing is no different than other industries in its need for intra-company data exchange. And, in real-world terms, pharmaceutical production needs clean data exchange more so than many other enterprises.

HANFORD Pharmaceuticals is a forward-thinking company. HANFORD's management and staff realize that in order to maintain the highest product standards – and to repeatedly refill clients' orders without deviating from an established norm – modern technology is mandatory.

The Hanford Pharmaceuticals Network Operations Center (NOC) manages a wide range of services and provides network support for the Hanford campus. In providing these services, the NOC offers oversight of problem, configuration and change management, network security, performance and policy monitoring, reporting, quality assurance, scheduling, and documentation. The NOC provides a structured environment that effectively coordinates operational activities with all customers and vendors related to the function of the network.

Investment in cutting edge technology brings HANFORD managers and customer groups together not only with data exchange but for the entire pharmaceutical manufacturing process.

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If what has been described about HANFORD's capabilities and professionalism sounds appealing and can help your company to meet its pharmaceutical product goals, then contact Scott Brown, Director, New Business Development. He will provide you with a full explanation of the entire process and answer any questions you have.