I recently recalled an experience from my distant past, and realized it was rife with cold-chain parallelism. I thought you might enjoy the humor.

Years ago, in my Sierra Club-Erehwon-poster-child days of college, I participated in a geology field study class over the course of a summer. It culminated with a group of about twenty planning a backpacking trip through the Grand Canyon. We were paired with essentially total strangers and were co-responsible for completion of the course. My partner admitted to me that he was not all that experienced with desert hiking - and that this was for him, just a cheap summer vacation.

We were to hike the length of the Kiabab Trail from the North Rim; and not to push it, we would traverse the 14.5 miles of switch-backs and 5,840 feet in vertical elevation to Phantom Ranch in two days, and back out again in another two. It was August and the climate on the rim (elev. 8,000 ft.) was beautiful; the daytime temperatures ranged between 45-75 degrees F.

I prepared for our four day study of the canyon. I had a day-pack stuffed with the essentials: a change of socks, shirt, and shorts which I could wash and wear on alternating days. I also had enough freeze dried food (to cook in their foil pouches) high-carb snacks, fruit and trail-mix for four-plus days. I included a backpacking stove, eating utensils, a space blanket and bivouac bag for sleeping, a first aid kit, sunscreen, and waterproof matches. On my belt I had a Swiss Army Knife, a compass, a whistle and four 1 quart canteens of water. In all, I  carried about 14 lbs of gear.

I grabbed my camera, a wide brimmed hat and in layered clothing, scrambled through the parking lot at dawn. I met my travel companion for the next four days at the trail head. He lumbered toward me hunched over from the weight of his over-stuffed aluminum frame backpack.

"Hey, Quasimodo, what's with the hump?" I cheerfully asked.

"What hump?" he said. I laughed. "Hi! It's Steve... and you're... Kevin?"

"That's right." Leaning forward, we shook hands.

He shrugged under the weight of his backpack. "I wasn't quite sure what to bring and what to leave behind. I am very risk-averse. I'd rather be safe than sorry!" He exclaimed. He wrestled his backpack to the ground and verbally ran through his inventory checklist. "I'm prepared for just about any contingency." and displayed each item as he extricated it from his pack. " I brought an extra pair of shoes, just in case... clothes... and more clothes... a sweater... water purifying kit, my snake-bite kit... a big old Mag light - shines to 1000 feet and extra batteries... just in case" he said turning the beacon on and off a few times - "and look! A mirror... you know? To use as a reflector to signal to rescuers if we get lost. What? It could happen!" He insisted.

I nodded in agreement. He continued. "Man, this camp stove and extra fuel canister takes up a lot of space."He flashed his geology text book "Can't forget this... and... notebooks, 2 pens. Mess kit... air mattress and a foot pump -  and I can't wait to use my new goose-down, mummy sleeping bag! It cost me $150.00 but it's good to 10 below zero! Oh yeah, I brought rain gear, a tent and rain fly, too. You know how miserable camping can be if you get wet." He said, smartly. "Where's your stuff?"

Munching on a handful of granola, I gestured in the direction of my day-pack on the nearby bench.

Confused, he replied, "That's it? That's all you're bringing?"

I assured him it was all I needed.

We gazed upon the spectacular dawn as the rising sun began to paint subtle changes that ran like watercolors down the walls of  Bright Angel Canyon. It is an awesome, powerful view and still my favorite place and favorite time of day at the Grand Canyon.

"Wow... damn big hole, isn't it?" He said solemnly. 

"That's one way to look at it."

"And it's way too early for this. I'd love to get some breakfast before we start?" He griped.

I offered him a handful of granola. He declined. "No time. We've got to get a head start on the heat." I said.

"Heat? I'm freezing! I can see my breath! Dude, if you need anything, let me know, I probably have got it in here." He said, patting his backpack.

"Right, thanks." I said. "Do you think you're really going to need all that stuff?"

"You never know, now do you?" He replied.

I wondered aloud, "What do you think that pack weighs?"

"I don't know... 40 pounds maybe. Don't worry." He struck a bodybuilding pose, "I can handle it."

I watched as he re-secured his gear. "What's with the big coil of rope?"

"Rattle Snakes, man! I got thirty feet... 3/4 inch... genuine hemp!" He began to demonstrate. "You put it on the ground at night in a circle, like this, around where you're sleeping. Snakes won't cross it... it's too rough on their belly." He coughed, coiling the now dusty rope. He saw that I was biting my lip. 'What? It could happen!" He barked.

"Kinda like a force-field!" I said tongue-in-cheek.

"Exactly! Besides, we can use it as a rescue rope, you know, if ... something happens." He added in a somber tone.

"That's great, Yule Gibbons, but don't you think it's a little short?" I looked over the edge of the canyon. "If we really get desperate, we can always toke on a length of it and use the rest for a noose." I retorted.

"You're a funny guy. We'll see who is prepared for the worst case scenario and who isn't." He grunted as he hoisted his backpack and teetered as he slung it onto his shoulders. He dismissed me with a wry smile when I told him they have a rent-a-Sherpa at the lodge.

"Are your canteens filled?" I asked as we stepped onto the trail.

"Yep! I just brought one 'cuz I didn't want to get weighted down with water. It's 8 pounds a gallon, you know. Besides it's not going to be hot today and I figure I can refill along the way." He explained.

I immediately stopped and turned toward him. "Hey, Meriwether Lewis, you do know where we're going, right?"

"Duh?" He exclaimed, pointing down the trail. "And who is Meriwether Lewis? Is that her?" pointing to another member of our group on the trail.

"Uh... I'm not sure but the guy she's with is named... Clark, I think." I said sartorially.

"Oh yeah, met him yesterday. Hi Clark!" He said as he waved. The man turned and faintly waved back, looking completely confused.

"You seem to be making a lot of assumptions." I said. "You got a map?" 

"I thought you had one." He said quizzically.

"I do. But what if we get separated?" I asked curiously.

"He thought for a moment. "Well... the trail only goes down or up, right? I mean, how tough can it be to figure that out? If you're walking downhill you're headed toward the river. If you're walking uphill you're headed toward the rim. Simple enough. You're either at the bottom on the one end or at the top at the other end. There really isn't much in between, is there?" Now chortling at my expense, he stepped by me.

"Well," I shouted, " if you had a map you would know there is no water to refill along the way. There's no water until we reach Roaring Springs Camp on Bright Angel Creek. It's a half a days walk, 4 miles down." I said emphatically.

He looked back at me. "A half a day to walk four miles?" He rolled his eyes and laughed. "I'll try to keep up."

I knew we needed to maintain a steady, brisk pace to get as deep into the canyon as we could before the sun hit the north wall and the temperature skyrocketed. We began walking down the trail, back through time - about 545 million years by day's end. I had every intention to reach The Great Unconformity by evening. (Sorry, I'm slipping back to those heady Paleozoic days when I was a Geomorphology major). We were no farther than a mile or so down the canyon when my traveling partner peered at my canteen bottles around my waist-belt and contritely asked,  "You got any extra water you can share?" 

Needless to say, the trip was a disaster - at least for my novice outdoor lab partner. He struggled silently in the 100 degree heat under the weight of his ridiculously unnecessary provisions and could only make it back as far as Cottonwood Camp on day three when he admitted he could walk no farther. He had two alternatives at this point: jettison most of his belongings along the trail (more common than you'd think) and try to walk out, or suffer the indignity of having to pay exorbitantly to be "dragged-out" by mule. He chose the latter.

A small crowd of hikers had gathered at the camp's water pump as a dust-weary cowboy descended from the canyon walls on a mule with another mule in tow. "Drag out! Drag out! Where's my drag out!" He shouted as his words echoed off the Redwall Limestone. They sauntered into camp. I could sense my fellow student's humiliation as he approached the grizzled mule-driver. He awkwardly yanked himself into the saddle of the disinterested mule and clung to the saddle horn in desperation - defeated - and with his head on his chest. The crowd stood and watched in silence as the cowboy mumbled and lashed the backpack onto the mule's rump. Within moments the four of them had disappeared up the trail.

The cost of the rescue was more than what my partner paid for his new sleeping bag. He was waiting for me and the rest of the group on the rim the following day. We had to spot him some cash in order to meet the $160 drag-out fee and before they would let him have his gear back.

* * *

An inadequate understanding of the environment you are about to enter can lead you to prepare for the worst-case scenario but still leave you woefully ill-prepared for reality. We all fall victim to it at one time or another to varying degrees. Unfortunately, for many pharmaceutical companies it takes the packaging equivalent of a "drag-out" to realize the far-reaching costs of this assumption.

With more than 20 years of cold-chain experience, I have yet to see, or have explained to me, exactly what is a worst-case scenario? That phrase, like the rubbing of two pieces of EPS together, runs shivers down my spine. As far as I'm concerned it should be stricken from the vocabulary of every self-respecting cold-chain packaging engineer - like "oops!" from the vocabulary of a surgeon, or "honestly" from the vocabulary of a Tarot card reader.

That said, spring training is in full swing and baseball is just around the corner. With opening day just a month away, I am beginning to prepare for my beloved Chicago Cubs to make it to the World Series in October.

What? It could happen!  But in reality... what are the odds?

I've had a spate of inquiries regarding USP General Chapter <1079> lately and since my flight from Chicago is delayed by more than three hours this evening, I thought now would be a good time to address them.

First, some background... the United States Pharmacopeia (USP) is an independant, science-based public health organization. They are the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards. USP's standards are also recognized and used in many other countries outside the United States. In other words, they make the rules and the FDA enforces the rules.

In June, 2005, the USP published General Chapter <1079> Good Storage and Shipping Practices. It is a general information chapter "intended to provide general guidance concerning storing, distributing, and shipping of Pharmaceutical preparations." This 'general guidance' applies to warehouses, pharmacies, freight service providers, repackagers and shipping docks, in addition to manufacturers of pharmacopeial products. In essence, anyone in the cold-chain custody.

"It is meant to inform" says Claudia Okeke, Associate Director Information & Standards Development , USP and member of USP Expert Committee on Packaging, Storage and Distribution. 

It is important to note that guidance is not enforcable by law. However, with limited guidance in cold-chain storage and distribution, the FDA makes significant use of USP's guidance. Since USP sets the bar when it comes to standards, can enforcable action be far behind? On the surface, <1079> seems reasonable and thorough. But it is not without hardship and impractibility to the industry.

This is why groups like the PCCDG, the C3 and Pharma Logistics Forum, etc., are so important to industry. Who better than industry knows what are the best current practices? Or what the limitations of technology are? What's practical? What's needed?By working with USP and FDA, industry can have direct influence and impact on regulation that can affect the future of cold-chain.

More on this later. My flight will soon be boarding. With any luck, I'll make it in to Philadelphia by midnight...

For those of you who can't get enough cold chain, the Parenteral Drug Association pda will be hosting a web conference Tuesday, February 14th on the Role of PDA's Technical Report No. 39 in Navigating Today's Cold Chain Regulatory Climate.

Also on PDA's agenda, their first ever Cold Chain Conference which will be held at their headquarters in Bethesda, MD March 27-28.Details for both events are available at their web site.

Sensitech , intergraters of temperature monitoring / track and trace and data management  in Beverly, MA will be hosting a FREE web conference March 7th at 2:00 PM EST on "The Impact of USP General Chapter <1079> on Cold Chain Management". Your host, the ubiquitous Dr. Rafik H. Bishara.

After more than twenty years in solving the cold-chain packaging riddle - trying to maintain 2-8C,  I believe I found the place where no such challenge exists. That illusive temperature range seems forever a constant here among the bucolic fields and fens of Hertfordshire, England. 

And while engineering solutions for cold-chain has been a constant pursuit that may to some seem droll and unexciting, I feel compelled to relate to you a recent cold-chain poltergeist experience. 

My day-long journey came to a close amid one of England's legendary fog-shrouded evenings, at the end of a narrow  drive - through a wood which opened onto a broad, flat lawn on the outskirts of the medieval town of Tring. Perched in the middle of the lawn was my destination for the night: Pendley Manor, a beautiful, but quirky Victorian Estate-turned-hotel. pendley-manor.co.uk 

The front lamps near the two-story main entrance glowed with halo's through the fog and the headlamps from my colleague's car revealed no other in the parking lot. We said our good-bye's and each step echoed with the hollow sound of the wheels of my suitcases as I towed them along the walkway. I stopped in front of the entrance for a moment and craned my head upwards in appreciation of the grand architecture – although I could not see the top as it disappeared in the fog, as did my colleague's retreating tail lights.

I awoke the night receptionist as I clamored in – a plump older gentleman with a throaty voice who boastfully displayed long, wispy, mutton-chop sideburns of pure white. He had a rosy, cherubic face to match his disposition, and at the very tip of his long, pointed nose rested a pair of reading glasses. He looked like a badger.

With my room key in hand, I entered the massive, dimly lit foyer lined with life sized portraits of old British gentry who seemed to watch me as I plodded my way up the creaky Mahogany staircase. Their dignified poses, opulent dress and importance to society were of no consequence to me as I clumsily climbed to the myriad of dark hallways above. 

My room, one of 79 at the manor, was dimly lit and adorned with a gigantic four-poster bed, floor-to-ceiling tapestries, flowery carpeting and a 14 foot ceiling. The bathroom was ancient but spotlessly clean and cozy with a slipper tub and porcelain water fixtures. I pulled back the heavy window drapery and was startled to catch a glimpse of a ghostly image ‘falling’ off the balcony. I stepped back, waited a few seconds, and drew a deep breath before leaning forward - only to bang my head on the interior storm window while trying to view the empty parking lot below which was illuminated by a single lamp that hung from a nearby tree.

Tired as I was, I grabbed my digital camera and was delighted with prospect of exploring the old mansion.

Tapestries loomed above me. Giant oriental urns and over-stuffed chairs were placed throughout the halls. Scenes of foxhunts, men and women of society, and gatherings of various occasions were handsomely framed along the walls. The uneven floors squeaked and groaned as I slowly but alertly made my way up and down stairs, through low doors and around the corners of one winding, empty hall after another; some filled with noticeably sudden chills and drafts. I slipped past the lounge, a well appointed dining room, a ballroom, and spa with a pool, sauna and whirlpool. They all quietly awaited guests that never arrived that evening. All the halls on all levels eventually led back to the grand foyer.

It was on to the basement, whose foundation I would later learn, dated back to 1066. These halls were exceedingly narrow and I had to bow in order to get my 6'1" frame past the arches overhead. The maze of hallways led nowhere. There was a gymnasium, a dance studio and exercise room and a door, marked (oddly enough) 'do not open this door'. I saw a light spilling from a doorway at the end of the hall and decided to investigate. I thought I heard footsteps as I approached. It was the snooker room. A massive and ornate green felt table sat in the middle of the room. Billiard balls were scattered around the table as if in mid-game, and a pool cue leaned precariously against one side. But I saw no one. I quickly found the nearest staircase to the main floor. I headed in the direction of muted voices echoing from the foyer. But the foyer was empty. I peeked into the reception area. The badger was watching BBC on the television. Were those the voices I heard? By now I was feeling a bit anxious and decided to go back to my room; applying all three locks to the door - just for good measure.

The room was dark and cold and I could not find a thermostat. I tried calling home - for it would be late afternoon - but my cell phone read "no signal". No sooner than I had entered my room I began to hear things. Doors opening and closing, hurried tip-toeing, silverware dropping and water running through banging pipes buried deep within the walls. Exhausted, I drifted off to sleep in a chair in the corner of the room farthest from the door. Such a restless sleep I had filled with bizarre dreams of Dutchmen's clogs left in the hallway, a Chinese woman in a cotton nightgown wandering the halls talking to herself in a language I could not recognize and I saw shadows cast onto the floor from the sliver of light beneath my door. I heard strange, haunting cries and cackling. When daylight came, I found myself lying on the edge of the bed still in my clothes with the heavy bedspread pulled over me. I saw the shadows like those from my dreams in the sliver of light coming from under the door and heard the clear voices and chatter of the women from housekeeping - though they were speaking in a language I could not identify. I staggered over to the window and pulled back the drape. I yelped when I saw what looked to be a Peacock, completely void of color, perched on the ledge of my balcony, staring wistfully at me. Was I still dreaming? The camera! Still groggy, I quickly took a picture of the odd looking bird and searched for my Blackberry to check for the time -  1:10 a.m.? Could this be right? It was daylight after all. The signal was strong. I decided to lie back down. I awoke to the staccato ring of my room phone. It was the front desk. "Mr. O'Donnell, your driver is here to take you to the airport, yes?" I heard the young woman say with a distinct Polish accent. I asked if the driver would be kind enough to wait, and I appeared, tired and disheveled at the front desk some thirty minutes later. Before entering his car, I heard the same strange cries and cackling that I heard in my dreams a few hours before. I looked to see what it was. Across the lawn I saw several Peacocks, including one of white, state-fully prancing and pecking at the grass. "Are those... Peacocks?" I asked in disbelief. "Indeed they are sir. Pendley is famous for them - including that albino one over there." Said the driver, as he carefully placed my bags into the car.

On the drive to Heathrow I related the peculiar experiences of my stay to the driver. "I'm not surprised, sir. You're not the first to tell me that." He chuckled. "Everyone around here knows that Pendley is haunted, sir."

Haunted, I thought? I don't believe in such things. As an engineer, I tend to rationalize everything. But this was the most peculiar experience I have ever had and I think I would rather leave it that way. I suppose I could explain most of it. But this makes for a much more interesting story - don't you think?

Attached for your amusement are some digital photographs of Pendley. Enjoy.

The fourth annual IQPC sponsored cold-chain conference was held in Brussels, Belgium, on January 31st and February 1st, 2006. The event was well attended and the comments were mixed with about 170 delegates, mostly from the EU states in attendance. This was about twice the size of last years conference as interest in cold chain management and best practices continues to gain momentum. There was, for the first time I can recall, representation from a commercial supplier from Russia.

There was plenty of new, valuable discussion on regulatory trends presented by John Taylor of MHRA in the UK, Greg McGurk from the Irish Medicines Board , and Rafik Bishara from the PDA in the U.S.

Of particular interest was a presentaion made by Petra Kleditzsch, Merck KGaA, regarding their efforts in forming a multi-pharmaceutical team within Europe who are developing a guideline on validation methods for refrigerated trucks, and quality agreements for cold-chain partners and suppliers. Merck has long been in the forefront of developing sound cold-chain management practices and their leadership and willingness to share information among their colleagues in the industry is admirable.

However, the general comments I heard from the attendees echoed what many in North America have recently expressed. Many delegates complained about the diminishing return on the value of repetitive presentations year-to-year and the increased cost to their organizations. Others were dissatisfied with the amount of presentations which differed from those outlined in the program. What can commercial conference organizations do to remain viable, sustain interest and encourage additional attendance?

Your comments welcomed...